This section highlights FDA-related milestones and regulatory updates for drugs developed by Bristol Myers Squibb (BMY).
Over the past two years, Bristol Myers Squibb has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Abecma, Breyanzi, CAMZYOS®, CheckMate, CheckMate, COBENFY, and Deucravacitinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Abecma (idecabtagene vicleucel) FDA Regulatory Events
Abecma (idecabtagene vicleucel) is a drug developed by Bristol Myers Squibb for the following indication: Relapsed and Refractory Multiple Myeloma.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Abecma (idecabtagene vicleucel)
- Announced Date:
- September 25, 2024
- Indication:
- Relapsed and Refractory Multiple Myeloma
Announcement
2seventy bio, Inc announced that the Company, in partnership with study sponsor Bristol Myers Squibb (BMS), will discontinue enrollment in its ongoing Phase 3 KarMMa-9 study evaluating Abecma® (idecabtagene vicleucel; ide-cel) with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma (NDMM) who have suboptimal response to autologous stem cell transplant.
AI Summary
2seventy bio, Inc. and Bristol Myers Squibb (BMS) have announced that they will stop enrolling new patients in the Phase 3 KarMMa-9 study. This trial was evaluating Abecma® (idecabtagene vicleucel) combined with lenalidomide maintenance versus lenalidomide maintenance alone. The study was focused on patients with newly diagnosed multiple myeloma (NDMM) who did not have a strong response to autologous stem cell transplant.
The decision comes amid improvements in the NDMM treatment landscape, which have resulted in fewer eligible patients than initially expected. By discontinuing enrollment, the companies expect to save over $80 million in near-term costs and move closer to breakeven by 2025. Both partners remain committed to the value and potential of Abecma in addressing the needs of multiple myeloma patients.
Read Announcement- Drug:
- Abecma (idecabtagene vicleucel)
- Announced Date:
- April 5, 2024
- Indication:
- Relapsed and Refractory Multiple Myeloma
Announcement
Bristol Myers Squibb and 2seventy bio, Inc announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial.
AI Summary
On April 4, 2024, Bristol Myers Squibb and 2seventy bio announced that the U.S. Food and Drug Administration approved Abecma® (idecabtagene vicleucel; ide-cel) for adult patients with relapsed or refractory multiple myeloma. This new approval is for patients who have already received two or more treatment lines, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
The decision was based on the results from the Phase 3 KarMMa-3 trial, which showed that Abecma tripled progression-free survival and reduced the risk of disease progression or death by 51% compared to standard therapies. Administered as a one-time infusion, Abecma offers patients extended, treatment-free intervals while maintaining a well-established safety profile. This milestone expands treatment options for multiple myeloma patients and underlines both companies’ commitment to advancing cell therapy and increasing global manufacturing capacity.
Read Announcement
Breyanzi (lisocabtagene maraleucel) FDA Regulatory Timeline and Events
Breyanzi (lisocabtagene maraleucel) is a drug developed by Bristol Myers Squibb for the following indication: Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Breyanzi (lisocabtagene maraleucel)
- Announced Date:
- June 26, 2025
- Indication:
- Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma.
AI Summary
Bristol Myers Squibb announced that the U.S. Food and Drug Administration has approved label updates for its CAR T cell therapies Breyanzi® for large B cell lymphoma and Abecma® for multiple myeloma. These changes are based on growing clinical and real-world evidence showing the therapies’ safety and effectiveness. The updates reduce certain patient monitoring requirements that previously added burdens on patients and healthcare providers. For instance, restrictions such as the driving prohibition and the need to remain near a treatment center after infusion have been cut significantly, from 8 and 4 weeks to 2 weeks, respectively. In addition, the FDA removed the Risk Evaluation and Mitigation Strategy (REMS) program for both products, streamlining treatment processes and potentially improving access to these life-saving therapies.
Read Announcement- Drug:
- Breyanzi (lisocabtagene maraleucel)
- Announced Date:
- June 16, 2025
- Indication:
- Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)
Announcement
Bristol Myers Squibb announced the first disclosure of the primary analysis results of the marginal zone lymphoma (MZL) cohort of TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory disease.
AI Summary
Bristol Myers Squibb announced the first disclosure of primary analysis results from the marginal zone lymphoma (MZL) cohort of the TRANSCEND FL study. This open‐label, global, multicenter Phase 2 single‐arm trial evaluated Breyanzi (lisocabtagene maraleucel or liso-cel) in adult patients with relapsed or refractory MZL.
The study showed encouraging results, with 95.5% of patients achieving an overall response and 62.1% obtaining a complete response. Notably, 88.6% of patients maintained their response at 24 months, suggesting a durable benefit from this one-time therapy. In addition, liso-cel demonstrated a consistent safety profile with low rates of severe adverse events. These findings support the potential of Breyanzi to transform treatment for patients with hard-to-treat MZL and reinforce Bristol Myers Squibb’s commitment to advancing cell therapy for lymphoma.
Read Announcement - Drug:
- Breyanzi (lisocabtagene maraleucel)
- Announced Date:
- March 14, 2025
- Indication:
- Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)
Announcement
Bristol Myers Squibb announced that the European Commission (EC) has granted approval to Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
AI Summary
Bristol Myers Squibb announced that the European Commission has approved Breyanzi® (lisocabtagene maraleucel), a CD19-directed CAR T cell therapy, for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This decision is based on compelling results from the TRANSCEND FL trial, where nearly all patients responded to treatment and 94.2% achieved a complete response.
The trial also showed lasting benefits, with about 75.7% of patients maintaining their response for at least 18 months. This approval makes Breyanzi an important new option for FL patients across the European Union and European Economic Area, offering hope for improved outcomes and quality of life for those with limited treatment alternatives.
Read Announcement- Drug:
- Breyanzi (lisocabtagene maraleucel)
- Announced Date:
- February 10, 2025
- Indication:
- Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)
Announcement
Bristol Myers Squibb announced the Phase 2 TRANSCEND FL trial evaluating Breyanzi®(lisocabtagene maraleucel) in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma met its primary endpoint in the marginal zone lymphoma (MZL) cohort.
AI Summary
Bristol Myers Squibb announced that its Phase 2 TRANSCEND FL trial evaluating Breyanzi® (lisocabtagene maraleucel) in adult patients with relapsed or refractory indolent B‐cell non-Hodgkin lymphoma met its primary endpoint in the marginal zone lymphoma (MZL) cohort. The trial showed a statistically significant overall response rate, while also reaching the key secondary endpoint of complete response rate. These results indicate that Breyanzi not only demonstrates strong efficacy in MZL but also maintains a manageable safety profile with durable responses. This achievement marks the fifth cancer type in which Breyanzi has shown clinical benefit, highlighting its potential in treating a broad range of B-cell malignancies. The study underscores the need for new treatment options for patients with MZL who relapse or become refractory to current therapies, and Bristol Myers Squibb plans to present further details at an upcoming medical meeting.
Read Announcement- Drug:
- Breyanzi (lisocabtagene maraleucel)
- Announced Date:
- January 31, 2025
- Indication:
- Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)
Announcement
Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
AI Summary
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi® (lisocabtagene maraleucel; liso-cel). This CD19-directed CAR T cell therapy is intended for adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The positive recommendation was based on the Phase 2 TRANSCEND FL study, where Breyanzi showed a 97.1% overall response rate and a 94.2% complete response rate.
The results demonstrated rapid, durable responses with a manageable safety profile, and 75.7% of patients maintained their response at 18 months. With this recommendation under review by the European Commission, Breyanzi may soon become a key treatment option for patients with FL, addressing an area of high unmet need. This move highlights Bristol Myers Squibb’s commitment to expanding innovative therapies in challenging cancer indications.
Read Announcement- Drug:
- Breyanzi (lisocabtagene maraleucel)
- Announced Date:
- December 9, 2024
- Indication:
- Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)
Announcement
Bristol Myers Squibb announced results from 18 presentations reinforcing its leadership in cell therapy, with data demonstrating efficacy, durability and safety of currently available therapies in blood cancers and highlighting the potential of its pipeline for future indications including autoimmune diseases.
AI Summary
Bristol Myers Squibb (BMS) shared results from 18 presentations that underline its leadership in cell therapy. The data revealed that their approved therapies for blood cancers offer long-lasting responses and a strong safety profile. These studies confirmed that treatments, such as Breyanzi, continue to provide durable efficacy across various blood cancers including leukemia, lymphomas, and multiple myeloma.
In addition, BMS highlighted promising early results from its pipeline that may expand the use of cell therapies to treat autoimmune diseases like lupus. These results suggest that the company’s innovative research could lead to one-time treatments capable of resetting the immune system for sustained, treatment-free remission. Overall, the findings reinforce BMS’s commitment to advancing cell therapy and exploring new frontiers in treatment options beyond blood cancers.
Read Announcement- Drug:
- Breyanzi (lisocabtagene maraleucel)
- Announced Date:
- August 19, 2024
- Indication:
- Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)
Announcement
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Type II variation application to expand the indication for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
AI Summary
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Type II variation application to expand Breyanzi’s label. The expansion would allow Breyanzi® (lisocabtagene maraleucel), a CD19-directed CAR T cell therapy, to be used for treating adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. This validation confirms that the application is complete and will now undergo scientific review under the EMA’s centralized procedure.
The application is supported by data from the Phase 2 TRANSCEND FL trial, which showed that Breyanzi produced deep, durable responses while maintaining a consistent and manageable safety profile. These promising results highlight Breyanzi as a valuable treatment option for a patient group with significant unmet needs in FL therapy.
Read Announcement- Drug:
- Breyanzi (lisocabtagene maraleucel)
- Announced Date:
- June 3, 2024
- Indication:
- Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)
Announcement
Bristol Myers Squibb announced data from three studies evaluating Breyanzi® (lisocabtagene maraleucel; liso-cel), including long-term data with three-year follow-up from the Phase 3 TRANSFORM trial of Breyanzias a second-line treatment in patients with relapsed or refractory large B-cell lymphoma (LBCL), results from a subgroup analysis evaluating the efficacy and safety of Breyanzi by number of prior lines of therapy in the mantle cell lymphoma (MCL) cohort of the TRANSCEND NHL 001 trial, and results from a subgroup analysis assessing the efficacy and safety of Breyanzi based on use of bridging therapy in the TRANSCEND FL trialin relapsed or refractory follicular lymphoma (FL).
AI Summary
Bristol Myers Squibb presented new data on Breyanzi® (lisocabtagene maraleucel) from three recent studies. In the Phase 3 TRANSFORM trial, three‐year follow-up results in patients with relapsed or refractory large B-cell lymphoma (LBCL) showed ongoing event-free survival and durable responses when Breyanzi was used as a second-line treatment, with improvements in progression-free survival and overall response rates compared to standard therapy.
Additionally, a subgroup analysis from the mantle cell lymphoma cohort of the TRANSCEND NHL 001 study found that Breyanzi provided consistent clinical benefits, regardless of the patient’s number of prior treatment lines. A further analysis from the TRANSCEND FL trial demonstrated that Breyanzi maintained high efficacy and a reliable safety profile in relapsed or refractory follicular lymphoma patients, regardless of whether bridging therapy was used. These findings highlight Breyanzi’s potential as a versatile treatment option for diverse B-cell malignancies.
Read Announcement- Drug:
- Breyanzi (lisocabtagene maraleucel)
- Announced Date:
- May 30, 2024
- Indication:
- Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)
Announcement
Bristol Myers Squibb announced the U.S. Food and Drug Administration (FDA) has granted approval for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
AI Summary
Bristol Myers Squibb announced that the FDA has approved Breyanzi® (lisocabtagene maraleucel), a CD19-directed CAR T cell therapy, for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL). This treatment is intended for patients who have undergone at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor, addressing a critical need for those with an aggressive form of MCL that is often resistant to standard therapies.
Administered as a one-time infusion of 90 to 110 million CAR-positive T cells, Breyanzi demonstrated a high overall response rate in clinical trials, offering a promising new option for patients with few effective treatment alternatives. This significant FDA approval expands the reach of CAR T cell therapies to the broadest range of patients with B-cell malignancies, marking an important step forward in personalized cancer care.
Read Announcement- Drug:
- Breyanzi (lisocabtagene maraleucel)
- Announced Date:
- May 15, 2024
- Indication:
- Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)
Announcement
Bristol Myers Squibb announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
AI Summary
Bristol Myers Squibb announced a significant breakthrough as the U.S. Food and Drug Administration (FDA) granted accelerated approval for Breyanzi® (lisocabtagene maraleucel; liso-cel). This new therapy is a CD19-directed chimeric antigen receptor (CAR) T cell treatment designed for adult patients with relapsed or refractory follicular lymphoma (FL), specifically for those who have already received two or more prior lines of systemic therapy.
The accelerated approval pathway speeds up the process, allowing patients quicker access to treatments that address serious unmet medical needs. Breyanzi offers a promising new option for individuals whose FL has not responded to conventional treatments. This step highlights the potential of CAR T cell therapies to provide meaningful clinical benefits and underscores ongoing efforts to improve outcomes for patients facing challenging cancer diagnoses.
Read Announcement
CAMZYOS® (mavacamten) FDA Regulatory Events
CAMZYOS® (mavacamten) is a drug developed by Bristol Myers Squibb for the following indication: For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CAMZYOS® (mavacamten)
- Announced Date:
- September 1, 2024
- Indication:
- For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy
Announcement
Bristol Myers Squibb announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension (LTE) study evaluating CAMZYOS® (mavacamten) in adult patients with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
AI Summary
Bristol Myers Squibb announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension study, evaluating CAMZYOS® (mavacamten) in adults with NYHA class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The study data, collected over up to 3.5 years, showed that patients experienced consistent and sustained improvements in key echocardiographic measures. Specifically, there were notable reductions in resting and Valsalva left ventricular outflow tract gradients and in biomarkers such as NT-proBNP. These improvements also translated into better symptoms and functional capacity, with many patients reaching NYHA class I. Importantly, the safety profile of CAMZYOS remained stable with no new safety signals observed. The findings reinforce the established benefits of CAMZYOS, which is the first approved cardiac myosin inhibitor designed to target the source of symptomatic oHCM.
Read Announcement- Drug:
- CAMZYOS® (mavacamten)
- Announced Date:
- August 26, 2024
- Indication:
- For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy
Announcement
Bristol Myers Squibb announced the presentation of research across its robust cardiovascular portfolio at the European Society of Cardiology(ESC) Congress, taking place August 30 – September 2, 2024, in London, England. Data to be presented at the meeting includes long-term extension data evaluating the efficacy and safety profile of CAMZYOS® (mavacamten) up to 180 weeks (3.5 years) for the treatment of New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM), as well as data on behalf of the BMS-Pfizer Alliance on ELIQUIS® (apixaban) and the BMS-Johnson & Johnson Collaboration on milvexian.
AI Summary
Bristol Myers Squibb will showcase its latest cardiovascular research at the European Society of Cardiology (ESC) Congress in London from August 30 to September 2, 2024. The company will present long-term extension data for CAMZYOS® (mavacamten) demonstrating its sustained safety and effectiveness for nearly 3.5 years (180 weeks) in patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA class II-III). Additionally, Bristol Myers Squibb will share data on behalf of the BMS-Pfizer Alliance regarding ELIQUIS® (apixaban) and results from its collaboration with Johnson & Johnson on milvexian. These presentations emphasize the company’s robust cardiovascular portfolio and its commitment to advancing therapies that address unmet medical needs in cardiovascular diseases.
Read Announcement
CheckMate -067 FDA Regulatory Events
CheckMate -067 is a drug developed by Bristol Myers Squibb for the following indication: In Advanced Melanoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CheckMate -067
- Announced Date:
- September 15, 2024
- Indication:
- In Advanced Melanoma
Announcement
Bristol Myers Squibb announced 10-year follow-up data from CheckMate -067, a randomized, double-blind, Phase 3 clinical trial, which showed continued durable improvement in survival with first-line Opdivo® (nivolumab) plus Yervoy® (ipilimumab) therapy and Opdivo monotherapy, versus Yervoy alone, in patients with previously untreated advanced or metastatic melanoma.
AI Summary
Bristol Myers Squibb today released 10-year follow-up results from the Phase 3 CheckMate-067 trial in advanced melanoma. The study compared first-line treatments using Opdivo (nivolumab) plus Yervoy (ipilimumab), Opdivo monotherapy, and Yervoy alone. Results showed that patients receiving the combination therapy experienced the most durable improvement in survival, with 43% still alive after 10 years. In comparison, the median overall survival reached 71.9 months for the combination, 36.9 months for Opdivo alone, and only 19.9 months for Yervoy monotherapy. These findings mark the longest reported median overall survival in a Phase 3 advanced melanoma trial and demonstrate that the dual immunotherapy treatment can provide lasting benefits for patients with previously untreated advanced or metastatic melanoma.
Read Announcement
CheckMate -73L FDA Regulatory Events
CheckMate -73L is a drug developed by Bristol Myers Squibb for the following indication: in untreated, locally advanced stage III non-small cell lung cancer (NSCLC) that are not intended or eligible for curative surgery.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CheckMate -73L
- Announced Date:
- May 10, 2024
- Indication:
- in untreated, locally advanced stage III non-small cell lung cancer (NSCLC) that are not intended or eligible for curative surgery.
Announcement
Bristol Myers Squibb announced the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).
AI Summary
Bristol Myers Squibb announced that its Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in patients with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). The trial’s main goal was to show that the new treatment could delay the worsening of the disease for a longer period compared to current options. Unfortunately, the study did not demonstrate a significant improvement in PFS, which means that the therapy did not successfully keep cancer from progressing as expected. This result highlights the ongoing challenges of finding more effective treatments for aggressive lung cancer forms. The company and researchers will need to review the data and consider adjustments in future studies to better understand the treatment’s potential and to work toward new approaches that might offer better outcomes for patients.
Read Announcement
COBENFY FDA Regulatory Events
COBENFY is a drug developed by Bristol Myers Squibb for the following indication: For the Treatment of Schizophrenia in Adults.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- COBENFY
- Announced Date:
- April 22, 2025
- Indication:
- For the Treatment of Schizophrenia in Adults
Announcement
Bristol Myers Squibb announced topline results from the Phase 3 ARISE trial evaluating the efficacy and safety of Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia.
AI Summary
Bristol Myers Squibb presented topline results from its Phase 3 ARISE trial, which evaluated Cobenfy (a combination of xanomeline and trospium chloride) as an add-on treatment to atypical antipsychotics in adults with schizophrenia whose symptoms were not adequately controlled. The trial showed that while patients receiving Cobenfy experienced a 2.0-point greater reduction in the PANSS total score at Week 6 compared to those on placebo, this difference did not reach statistical significance (p = 0.11). Despite not meeting the primary endpoint, the trial indicated a numerical improvement in symptoms and confirmed that Cobenfy’s safety and tolerability profile was consistent with earlier studies. These results underscore the challenges of proving additional benefits when patients are already on treatment, and further analysis is planned to assess next steps with regulators.
Read Announcement- Drug:
- COBENFY
- Announced Date:
- September 26, 2024
- Indication:
- For the Treatment of Schizophrenia in Adults
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY™ (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.1
AI Summary
Bristol Myers Squibb announced that the FDA has approved COBENFY™ (xanomeline and trospium chloride), an oral medication for treating schizophrenia in adults. This approval marks the first new pharmacological class for schizophrenia in decades. Unlike traditional treatments, COBENFY works by targeting M1 and M4 receptors in the brain, rather than blocking D2 receptors, which may offer a different treatment option for patients.
The approval was based on promising results from the EMERGENT clinical program, where the medication showed statistically significant reductions in schizophrenia symptoms compared to a placebo. Additionally, COBENFY’s safety and tolerability were supported by both acute and long-term studies. This innovative treatment provides a new approach for managing a condition that affects millions, potentially changing the way schizophrenia is treated going forward.
Read Announcement
Deucravacitinib FDA Regulatory Timeline and Events
Deucravacitinib is a drug developed by Bristol Myers Squibb for the following indication: Moderate to severe plaque psoriasis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Deucravacitinib
- Announced Date:
- July 21, 2025
- Estimated Event Date Range:
- March 6, 2026 - March 6, 2026
- Target Action Date:
- March 06, 2026
- Indication:
- Moderate to severe plaque psoriasis
Announcement
Bristol Myers Squibb announced that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.
AI Summary
Bristol Myers Squibb announced the FDA has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) to treat adults with active psoriatic arthritis. The FDA set a PDUFA goal date of March 6, 2026, as the target for its decision. This application relies on results from the Phase 3 POETYK PsA-1 and PsA-2 trials, which showed significantly more patients on Sotyktu achieved at least a 20% improvement in disease signs and symptoms (ACR20) by Week 16 compared to placebo. Benefits persisted through 52 weeks with a consistent safety profile. If approved, Sotyktu could become the first oral TYK2 inhibitor for psoriatic arthritis.
Psoriatic arthritis affects joints and skin, and new oral treatments are in high demand. Bristol Myers Squibb looks forward to working with the FDA to support timely evaluation of Sotyktu for this indication.
Read Announcement- Drug:
- Deucravacitinib
- Announced Date:
- July 21, 2025
- Indication:
- Moderate to severe plaque psoriasis
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis.
AI Summary
Bristol Myers Squibb announced that the U.S. Food and Drug Administration has accepted for review its supplemental New Drug Application for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. The FDA has assigned a target action date of March 6, 2026 under the Prescription Drug User Fee Act.
The application is supported by positive results from the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 trials. In both studies, significantly more adults treated with Sotyktu achieved an ACR20 response—a measure of at least 20 percent improvement in disease signs and symptoms—at Week 16 compared with placebo. Data from POETYK PsA-2 further showed that clinical response improved or was maintained through Week 52.
Sotyktu is an oral, selective tyrosine kinase 2 inhibitor with the potential to be the first TYK2 inhibitor approved for psoriatic arthritis. If approved, it could offer adults living with this chronic, immune-mediated disease a new oral treatment option.
Read Announcement- Drug:
- Deucravacitinib
- Announced Date:
- June 11, 2025
- Indication:
- Moderate to severe plaque psoriasis
Announcement
Bristol Myers Squibb announced positive data from the pivotal Phase 3 POETYK PsA-1 trial (IM011-054) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA) who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD).
AI Summary
Bristol Myers Squibb announced positive results from the pivotal Phase 3 POETYK PsA-1 trial, showing that Sotyktu (deucravacitinib) significantly improved outcomes for adults with active psoriatic arthritis who had not been treated with biologic therapies. At Week 16, a notably higher percentage of patients treated with Sotyktu achieved an ACR20 response—54.2% compared to 34.1% with placebo—along with substantial improvements in joint and skin symptoms, overall disease activity, and quality of life.
The study also met important secondary endpoints, including ACR50, ACR70, PASI75, and minimal disease activity, further supporting the efficacy of Sotyktu. The safety profile observed was consistent with previous results, with no new safety signals identified. These promising results highlight the potential of Sotyktu as a new, oral, first-in-class TYK2 inhibitor for psoriatic arthritis.
Read Announcement- Drug:
- Deucravacitinib
- Announced Date:
- March 8, 2025
- Indication:
- Moderate to severe plaque psoriasis
Announcement
Bristol Myers Squibb announced positive data from the pivotal Phase 3 POETYK PsA-2 trial (IM011-055) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA).
AI Summary
Bristol Myers Squibb announced positive Phase 3 POETYK PsA-2 trial results for Sotyktu (deucravacitinib) in adults with active psoriatic arthritis. In the study, a significantly higher percentage of patients treated with Sotyktu achieved an ACR20 response—a 20% improvement in disease symptoms—compared with those given a placebo at Week 16 (54.2% vs. 39.4%). Additionally, more patients reached a PASI75 response, showing better skin improvements, and reported higher quality of life scores compared to placebo. Sotyktu was generally well-tolerated when compared with both placebo and apremilast, and no new safety issues were noted. These promising data support the potential of Sotyktu as an effective oral treatment option that can address both joint and skin symptoms in psoriatic arthritis, offering hope to patients with this complex, immune-mediated disease.
Read Announcement- Drug:
- Deucravacitinib
- Announced Date:
- February 17, 2025
- Indication:
- Moderate to severe plaque psoriasis
Announcement
Bristol Myers Squibb announced new five-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis.
AI Summary
Bristol Myers Squibb announced promising five‐year data from the POETYK PSO long‐term extension trial evaluating Sotyktu (deucravacitinib) in adult patients with moderate‐to‐severe plaque psoriasis. The study demonstrated that Sotyktu maintained a consistent safety profile over more than 5,000 patient‐years, with no new safety signals observed. Notably, nearly half of the continuously treated patients achieved a PASI 90 response at Year 5, similar to results seen in earlier assessments. Other clinical efficacy measures, such as PASI 75 and static Physician’s Global Assessment (sPGA 0/1), were also sustained through the five years of treatment. These findings underscore Sotyktu’s potential as a transformative oral therapy and the first TYK2 inhibitor serving as a long‐term treatment option for patients with moderate‐to‐severe plaque psoriasis.
Read Announcement- Drug:
- Deucravacitinib
- Announced Date:
- December 23, 2024
- Indication:
- Moderate to severe plaque psoriasis
Announcement
Bristol Myers Squibb announced results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase 3 trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA).
AI Summary
Bristol Myers Squibb announced positive Phase 3 results from the POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055) trials evaluating Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). In these studies, a significantly higher number of patients treated with Sotyktu achieved an ACR20 response—a 20 percent improvement in disease signs and symptoms—compared to those on placebo after 16 weeks. The results also met important secondary endpoints related to overall PsA activity, supporting the drug’s potential benefit.
Sotyktu was well-tolerated and demonstrated a safety profile consistent with earlier clinical reports. These data indicate that Sotyktu, as an oral selective TYK2 inhibitor, might become an important option for patients with PsA in need of effective treatments. Bristol Myers Squibb plans to share more detailed findings at upcoming medical conferences.
Read Announcement- Drug:
- Deucravacitinib
- Announced Date:
- September 27, 2024
- Indication:
- Moderate to severe plaque psoriasis
Announcement
Bristol Myers Squibb announced positive results from the Phase 3b/4 PSORIATYK SCALP trial evaluating Sotyktu (deucravacitinib) for the treatment of patients with moderate-to-severe scalp psoriasis, including those with less extensive overall psoriasis.
AI Summary
Bristol Myers Squibb announced positive results from the Phase 3b/4 PSORIATYK SCALP trial, which evaluated Sotyktu (deucravacitinib) for treating moderate-to-severe scalp psoriasis, including patients with less extensive overall psoriasis. At Week 16, nearly half of the patients treated with Sotyktu (48.5%) achieved clear or almost clear skin on the scalp compared to only 13.7% on placebo. The trial met all primary and key secondary endpoints, showing statistically significant improvements in measures such as the Psoriasis Scalp Severity Index and scalp-specific itch reduction. The findings highlight Sotyktu’s effectiveness as a once-daily oral treatment, offering potential relief for the approximately 80% of psoriasis patients who experience scalp involvement with associated symptoms like itching, flaking, pain, and bleeding. The safety profile observed was consistent with previous studies, reinforcing Sotyktu’s promise as a new treatment option for scalp psoriasis.
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KarXT (xanomeline-trospium) FDA Regulatory Timeline and Events
KarXT (xanomeline-trospium) is a drug developed by Bristol Myers Squibb for the following indication: Healthy Elderly Volunteers.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- January 17, 2025
- Indication:
- Healthy Elderly Volunteers
Announcement
Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults.
AI Summary
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted their New Drug Application for KarXT, which is being developed to treat schizophrenia in adults. This important step could bring a new treatment option to over 8 million Chinese patients who currently face challenges with available therapies. Clinical trials have shown that KarXT significantly reduces symptoms of schizophrenia while offering a safety profile that is manageable. The acceptance of the application indicates that regulators see potential in this novel treatment approach, which could help patients experience fewer side effects compared to current medications. If approved, KarXT may pave the way for a fresh and innovative method to manage schizophrenia, potentially improving the quality of life for many patients in China and possibly influencing treatment practices globally.
Read Announcement- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- September 27, 2024
- Indication:
- Healthy Elderly Volunteers
Announcement
PureTech Health plc announced that KarXT (xanomeline and trospium chloride), which was initially invented and advanced by PureTech, has received U.S. Food and Drug Administration ("FDA") approval for the treatment of schizophrenia in adults.
AI Summary
PureTech Health plc announced that its drug KarXT—a combination of xanomeline and trospium chloride—has received U.S. FDA approval for treating schizophrenia in adults. Originally invented and developed by PureTech, KarXT overcomes previous tolerability issues, paving the way for a novel approach to treating neuropsychiatric conditions. With this approval, milestone payments worth $29 million have been triggered under agreements with Royalty Pharma and Karuna Therapeutics, the latter of which was acquired by Bristol Myers Squibb in March 2024.
Marketed by Bristol Myers Squibb under the name Cobenfy, this breakthrough marks a significant advancement in addressing schizophrenia with a treatment that represents the first new drug mechanism approved for the condition in over 50 years. PureTech’s innovation in drug development continues to demonstrate its impact on both clinical outcomes and future financial growth.
Read Announcement- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- April 6, 2024
- Indication:
- Healthy Elderly Volunteers
Announcement
Bristol Myers Squibb announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia.
AI Summary
Bristol Myers Squibb recently shared promising interim results from the Phase 3 EMERGENT-4 trial. This open-label extension study evaluated KarXT (xanomeline-trospium) in adults with schizophrenia over 52 weeks, focusing on long-term safety, tolerability, and efficacy. The trial showed a steady improvement in schizophrenia symptoms, with over 75% of participants experiencing more than a 30% symptom reduction on the PANSS scale at one year. Patients who switched from placebo in earlier trials began to see significant improvements as early as the second week after starting KarXT, and these gains were maintained throughout treatment. Additionally, improvements were also observed on the Clinical Global Impression-Severity scale. These findings support KarXT as a promising long-term treatment option for managing schizophrenia and add to the growing data from the EMERGENT program.
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KRAZATI (adagrasib) FDA Regulatory Timeline and Events
KRAZATI (adagrasib) is a drug developed by Bristol Myers Squibb for the following indication: for the treatment of patients with previously treated KRASG12C.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KRAZATI (adagrasib)
- Announced Date:
- June 21, 2024
- Indication:
- for the treatment of patients with previously treated KRASG12C
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI® (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
AI Summary
Bristol Myers Squibb announced that the FDA has granted accelerated approval for KRAZATI® (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with locally advanced or metastatic colorectal cancer (CRC) that carries the KRASG12C mutation. This approval applies to patients whose tumors have been identified with an FDA-approved test and who have already received chemotherapy regimens that include fluoropyrimidine, oxaliplatin, and irinotecan.
The decision was based on results from the Phase 1/2 KRYSTAL-1 study, which showed a 34% objective response rate in heavily pretreated patients. This approval offers a new treatment option for a historically challenging subset of CRC patients, bringing hope and potential improvements in outcomes while further clinical trials continue to verify the long-term benefit of the therapy.
Read Announcement- Drug:
- KRAZATI (adagrasib)
- Announced Date:
- June 1, 2024
- Indication:
- for the treatment of patients with previously treated KRASG12C
Announcement
Bristol Myers Squibb announced results from the Phase 3 KRYSTAL-12 study evaluating KRAZATI® (adagrasib)compared to standard of care chemotherapy in patients with locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) who had previously received platinum-based chemotherapy, concurrently or sequentially with anti-PD-(L)1 therapy.
AI Summary
Bristol Myers Squibb announced promising results from the Phase 3 KRYSTAL-12 study evaluating KRAZATI® (adagrasib) versus standard chemotherapy in patients with locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC). In this trial, patients had already received platinum-based chemotherapy along with anti-PD-(L)1 therapy. After a median follow-up of 9.4 months, KRAZATI showed a statistically significant improvement in progression-free survival, reaching a median of 5.5 months compared to 3.8 months with docetaxel. The overall response rate was also higher with KRAZATI, at 32% versus 9% for docetaxel. Additionally, KRAZATI induced a better intracranial response for patients with central nervous system metastases. No new safety concerns were reported, and the study continues to evaluate overall survival as a key endpoint.
Read Announcement- Drug:
- KRAZATI (adagrasib)
- Announced Date:
- April 8, 2024
- Indication:
- for the treatment of patients with previously treated KRASG12C
Announcement
Bristol Myers Squibb announced data from the cohorts of the Phase 1/ 2 KRYSTAL-1 study evaluating KRAZATI® (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC).
AI Summary
Bristol Myers Squibb announced promising data from the Phase 1/2 KRYSTAL-1 study evaluating KRAZATI® (adagrasib) in combination with cetuximab for patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer. In this trial, 94 patients were followed for a median of 11.9 months. The combination achieved a 34% objective response rate, meeting its primary endpoint. Additionally, the median progression-free survival was 6.9 months, and overall survival reached 15.9 months. The study also showed disease control in 85% of the patients, suggesting a potential benefit for a group that has limited treatment options. Safety findings for the combination were manageable and consistent with previous reports. These results highlight the importance of testing for KRASG12C mutations to identify patients who might benefit from targeted therapies like KRAZATI combined with cetuximab.
Read Announcement
Lenalidomide Capsules FDA Regulatory Events
Lenalidomide Capsules is a drug developed by Bristol Myers Squibb for the following indication: Multiple myeloma and myelodysplastic syndrome.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lenalidomide Capsules
- Announced Date:
- February 19, 2025
- Indication:
- Multiple myeloma and myelodysplastic syndrome
Announcement
Amneal Pharmaceuticals announced that the Company has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths.
AI Summary
Amneal Pharmaceuticals recently announced that it has received FDA approval for its Abbreviated New Drug Application (ANDA) for lenalidomide capsules in strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. This approval means that the company can now offer a generic version of lenalidomide, a thalidomide analogue used for treating several types of blood cancers. Amneal’s milestone is supported by a settlement agreement with Celgene, which licenses the necessary patents to manufacture and sell the generic drug in the U.S. starting January 31, 2026. The FDA clearance underlines the Company’s strong research and development capabilities and its commitment to expanding its portfolio of affordable medicines in competitive markets. Such innovations are expected to drive future growth and provide patients with access to vital treatments.
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Mavacamten FDA Regulatory Events
Mavacamten is a drug developed by Bristol Myers Squibb for the following indication: Symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Mavacamten
- Announced Date:
- April 14, 2025
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Bristol Myers Squibb announced the Phase 3 ODYSSEY-HCM trial evaluating Camzyos (mavacamten) for the treatment of adult patients with symptomatic New York Heart Association (NYHA) class II-III non-obstructive hypertrophic cardiomyopathy (nHCM) did not meet its dual primary endpoints of changes from baseline to Week 48 compared to placebo in the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2).
AI Summary
Bristol Myers Squibb announced that its Phase 3 ODYSSEY-HCM trial for Camzyos (mavacamten) in adults with symptomatic non‐obstructive hypertrophic cardiomyopathy did not meet its dual primary endpoints. The study failed to show significant improvements from baseline to Week 48 over placebo in both the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2). While the trial, which enrolled 580 patients, did not meet these endpoints, no new safety concerns were observed.
The findings emphasize that non-obstructive HCM may require different treatment approaches compared to obstructive HCM, where Camzyos has previously demonstrated clear benefits. The results provide important insights into the unique nature of non-obstructive HCM and highlight the need for further research. Bristol Myers Squibb expressed its gratitude to the patients and investigators and plans to share more detailed data with the scientific community in the future.
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Opdivo (nivolumab) FDA Regulatory Timeline and Events
Opdivo (nivolumab) is a drug developed by Bristol Myers Squibb for the following indication: Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Opdivo (nivolumab)
- Announced Date:
- May 28, 2025
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Halozyme Therapeutics, Inc. announced that Bristol Myers Squibb received European Commission (EC) approval of a new Opdivo® (nivolumab) subcutaneous formulation developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
AI Summary
Halozyme Therapeutics, Inc. announced that Bristol Myers Squibb has received European Commission approval for a new subcutaneous formulation of Opdivo® (nivolumab). This breakthrough approach uses Halozyme’s proprietary ENHANZE® technology, which incorporates the recombinant human hyaluronidase enzyme (rHuPH20) to enhance drug dispersion. The new formulation is approved for treating multiple adult solid tumors and offers flexible options for patients. It can be used as a standalone treatment, as maintenance therapy following intravenous nivolumab plus Yervoy® (ipilimumab) combination therapy, or together with chemotherapy or cabozantinib.
The subcutaneous injection, which takes just 3 to 5 minutes, promises to improve the treatment experience and reduce the burden for patients. The approval, valid in all 27 EU member states along with Iceland, Liechtenstein, and Norway, follows positive results from the Phase 3 CheckMate -67T trial, marking a significant advancement in cancer treatment options.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- May 22, 2025
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced the presentation of data across its oncology portfolio and pipeline at the 2025 American Society of Clinical Oncology (ASCO®) Annual Meeting to be held May 30-June 3 in Chicago, Illinois. Data from more than 80 company-sponsored studies, investigator-sponsored studies, and collaborations showcase results spanning more than 20 cancer types.
AI Summary
Bristol Myers Squibb announced that it will present data from its broad oncology portfolio and pipeline at the 2025 ASCO Annual Meeting in Chicago, Illinois. The company will share findings from over 80 studies, including company-sponsored, investigator-sponsored, and collaborative research, which cover more than 20 different cancer types. This range of data highlights results from innovative targeted therapies and novel treatment approaches, including studies that explore earlier treatment interventions aimed at improving patient outcomes. The presentations underscore the company’s commitment to advancing cancer care by refining personalized cancer treatments and supporting long-term patient survival. Attendees can expect to gain valuable insights into new strategies for managing various cancers as Bristol Myers Squibb continues to push the boundaries of oncology research and innovation.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- April 8, 2025
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo®(nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).
AI Summary
Bristol Myers Squibb announced that the FDA has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This decision marks an important advancement in immunotherapy, providing a new option for patients with a type of colorectal cancer that has been difficult to treat.
The approval was supported by data from the Phase 3 CheckMate-8HW trial. Results from the study showed a notable reduction in the risk of disease progression or death by 79% compared to chemotherapy and a 38% reduction compared to Opdivo monotherapy. These promising findings suggest that the dual immunotherapy approach could offer significant benefits in survival, addressing a high unmet need for patients with MSI-H/dMMR colorectal cancer.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- March 31, 2025
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Halozyme Therapeutics, Inc announced that Bristol Myers Squibb received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending approval of a new Opdivo® (nivolumab) subcutaneous formulation developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
AI Summary
Halozyme Therapeutics recently announced that Bristol Myers Squibb received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The CHMP recommended approval of a new subcutaneous formulation of Opdivo®, using Halozyme’s proprietary ENHANZE® technology. This new formulation employs the recombinant human hyaluronidase enzyme (rHuPH20) to allow for subcutaneous delivery of the cancer drug. It has been evaluated for several adult solid tumors across various treatment settings, including as a standalone treatment, as maintenance therapy following a combination of nivolumab with Yervoy®, or in combination with chemotherapy or cabozantinib.
The positive CHMP opinion paves the way for the European Commission to make a final decision, with a verdict expected by June 2, 2025. This development could significantly improve patient convenience and reduce the strain on healthcare resources.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- March 28, 2025
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a new Opdivo® (nivolumab) formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).
AI Summary
Bristol Myers Squibb announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new Opdivo® (nivolumab) formulation. This new version is designed for subcutaneous administration, coming as a solution for injection in a new 600 mg/vial strength. The subcutaneous formulation, which is co-formulated with recombinant human hyaluronidase (rHuPH20), is aimed at treating multiple previously approved adult solid tumors, either as a standalone treatment, as maintenance after combination therapy, or in combination with chemotherapy or cabozantinib.
The recommendation is based on positive clinical trial results demonstrating that the subcutaneous form has similar pharmacokinetics, efficacy, and safety compared to the intravenous formulation. The CHMP opinion now moves to the European Commission for further review, marking a significant step forward in immuno-oncology and potentially improving patient experience and healthcare efficiency across Europe.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- February 19, 2025
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study, which evaluated Opdivo® (nivolumab) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer (NSCLC).
AI Summary
Bristol Myers Squibb announced the final overall survival analysis from the Phase 3 CheckMate -816 study. This trial evaluated Opdivo® (nivolumab) used together with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC) who have tumors of 4 cm or greater or node-positive disease. The results showed a statistically significant and meaningful improvement in overall survival compared to chemotherapy alone. Prior results from the study had also met its primary endpoints of event-free survival and pathologic complete response, supporting the benefits of the combination therapy.
The safety profile for the Opdivo and chemotherapy regimen was consistent with earlier findings, with no new safety concerns observed. These findings highlight the potential of using Opdivo with chemotherapy to improve survival outcomes in patients with resectable NSCLC.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- January 25, 2025
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced results of an analysis from the three-arm Phase 3 CheckMate -8HW trial evaluating Opdivo® (nivolumab) plus Yervoy® (ipilimumab) versus Opdivo monotherapy across all lines of therapy, including first-line, for the treatment of microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC).
AI Summary
Bristol Myers Squibb announced new findings from the CheckMate –8HW Phase 3 trial, which compared the combination treatment of Opdivo (nivolumab) plus Yervoy (ipilimumab) against Opdivo alone in patients with MSI-H/dMMR metastatic colorectal cancer. In this study, after a median follow-up of 47 months, the combo treatment reduced the risk of disease progression or death by 38% compared with Opdivo by itself. Additionally, patients receiving the two-drug regimen showed higher rates of overall response at 71% versus 58% with monotherapy, and the progression-free survival rates at 12, 24, and 36 months were also better with the combination. These results, which support the benefit of using dual immunotherapy over a single agent, will be presented at the ASCO Gastrointestinal Cancers Symposium and published in The Lancet.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- October 3, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo®(nivolumab) for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy,followed by single-agent Opdivo as adjuvant treatment after surgery – otherwise referred to as perioperative therapy, which is used before and after surgery.1
AI Summary
Bristol Myers Squibb announced that the FDA has approved Opdivo® (nivolumab) for adult patients with resectable non-small cell lung cancer (NSCLC). This approval is specifically for patients with tumors that are equal to or larger than 4 cm or are node positive, and who do not have EGFR mutations or ALK rearrangements. The treatment is given as part of a perioperative therapy regimen, starting with a neoadjuvant approach that combines Opdivo with platinum-doublet chemotherapy before surgery. After surgery, patients receive single-agent Opdivo as adjuvant treatment. The decision was based on the positive outcomes of the CheckMate-77T trial, which demonstrated significantly longer event-free survival and a high pathologic complete response rate compared to chemotherapy alone. This milestone underscores a critical advancement in treatment options for early-stage NSCLC, aiming to reduce cancer recurrence and improve surgical outcomes.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- September 9, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced the presentation of nearly 60 abstracts of company-sponsored studies, investigator-sponsored studies, and collaborations from across its oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress 2024 to be held from September 13-17 in Barcelona, Spain.
AI Summary
Bristol Myers Squibb announced it will present nearly 60 abstracts at the European Society for Medical Oncology (ESMO) Congress 2024, held in Barcelona, Spain, from September 13-17. These abstracts include company-sponsored studies, investigator-sponsored studies, and collaborations across its comprehensive oncology portfolio and pipeline.
The data to be showcased cover a wide range of cancer treatments and highlight both early-phase trials and next-generation assets. The presentations will feature novel antibody-drug conjugates, protein degraders, and promising findings across various tumor types. Samit Hirawat, M.D., executive vice president and chief medical officer at BMS, stated that this work underscores the company’s enduring impact in oncology and commitment to advancing breakthrough cancer treatments to improve patient outcomes.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- August 21, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo®(nivolumab) plus Yervoy®(ipilimumab) as potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial.
AI Summary
Bristol Myers Squibb announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC). This move follows promising data from the Phase 3 CheckMate -9DW trial, which demonstrated a significant improvement in overall survival compared to current treatments such as lenvatinib or sorafenib. HCC, the most common form of liver cancer, is often diagnosed at an advanced stage when surgery is not an option, making new treatment avenues essential. The FDA has set a target action date of April 21, 2025, for reviewing the application, marking a hopeful step towards a new first-line therapy for patients in need.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- August 21, 2024
- Estimated Event Date Range:
- April 21, 2025 - April 21, 2025
- Target Action Date:
- April 21, 2025
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 21, 2025.
AI Summary
Bristol Myers Squibb announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) as a potential first‐line treatment for adult patients with unresectable hepatocellular carcinoma. This decision comes after the Phase 3 CheckMate –9DW trial showed improved overall survival compared to current therapies like lenvatinib or sorafenib. Importantly, the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of April 21, 2025, for the review of this application. If approved, the treatment could offer a new option for patients whose liver cancer cannot be treated surgically, addressing a significant unmet need with a manageable safety profile.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- July 19, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that the European Medicines Agency (EMA) validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
AI Summary
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a potential first-line treatment for adult patients with unresectable or advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy. This decision, based on the Phase 3 CheckMate -9DW trial, highlights that the combination significantly improved overall survival compared to the investigator’s choice of lenvatinib or sorafenib. The trial results point to improved outcomes along with a manageable safety profile. With around 62,000 liver cancer cases in the European Union each year and limited treatment options at advanced stages, this validation marks a key step in potentially offering a new dual immunotherapy option, initiating the EMA’s centralized procedural review to further evaluate the treatment’s benefits for patients.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- June 21, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated the extension application to introduce a new route of administration (subcutaneous use) for Opdivo® (nivolumab) that includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) across multiple previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib, based on the results from the Phase 3 CheckMate -67T study.
AI Summary
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its extension application for a new subcutaneous formulation of Opdivo (nivolumab). This submission introduces a solution for injection with a new strength of 600 mg per vial, intended for use across several previously approved adult solid tumor indications. The application covers treatment as monotherapy, as maintenance after combination therapy with nivolumab plus ipilimumab, or in combination with chemotherapy or cabozantinib.
The decision was based on positive results from the Phase 3 CheckMate‑67T study, which demonstrated that subcutaneous nivolumab is not inferior to the intravenous formulation in terms of pharmacokinetics and efficacy. This new subcutaneous option could greatly reduce the administration time to a fast three-to-five minute injection, potentially improving the treatment experience for cancer patients.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- June 4, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced the first presentation of results from the Phase 3 CheckMate -9DW trial evaluating the dual immunotherapy combination of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) compared to investigator's choice of lenvatinib or sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC).
AI Summary
Bristol Myers Squibb announced the first presentation of results from the Phase 3 CheckMate‐9DW trial at the 2024 ASCO® Annual Meeting. The study evaluated the dual immunotherapy combination of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) versus lenvatinib or sorafenib, which were given based on the investigator’s choice as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC).
The trial showed that the combination treatment significantly improved overall survival, with a median OS of 23.7 months compared to 20.6 months for the comparator arm. Additionally, the objective response rate more than doubled to 36% with Opdivo plus Yervoy, compared to 13% with lenvatinib or sorafenib, and responses were durable, with a median duration of around 30 months. The safety profile was consistent with previously known data, indicating a manageable risk profile for the combination regimen.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- May 29, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).
AI Summary
Bristol Myers Squibb announced that the European Commission has approved Opdivo® (nivolumab) in combination with cisplatin and gemcitabine as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. This approval marks the first time that an immunotherapy and chemotherapy combination is approved in the European Union for this type of cancer.
The decision is based on positive results from the Phase 3 CheckMate-901 trial. The study showed that the combination treatment significantly improved overall survival and progression‐free survival compared to chemotherapy alone. This new treatment option offers hope for patients, potentially improving outcomes and setting a new standard of care for those battling advanced urothelial carcinoma throughout the EU.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- May 21, 2024
- Estimated Event Date Range:
- December 29, 2024 - December 29, 2024
- Target Action Date:
- December 29, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with Halozyme's proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as "subcutaneous nivolumab") across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The updated goal date is December 29, 2024.
AI Summary
Bristol Myers Squibb announced that the FDA has updated the Prescription Drug User Fee Act (PDUFA) goal date for its Biologics License Application (BLA) concerning the subcutaneous formulation of Opdivo® (nivolumab). This product, co-formulated with Halozyme’s recombinant human hyaluronidase (rHuPH20), is being evaluated for use across all previously approved adult, solid tumor indications. It may be administered as a monotherapy, as maintenance following a combination with Yervoy, or in combination with chemotherapy or cabozantinib. The updated goal date for the FDA’s decision is December 29, 2024. The application builds on data from the CheckMate -67T Phase 3 trial, which demonstrated that the subcutaneous version has similar pharmacokinetics, efficacy, and safety compared to the intravenous formulation. If approved, this could offer patients a more convenient, subcutaneous option for PD-1 inhibitor therapy.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- May 6, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).
AI Summary
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy® (ipilimumab). The EMA’s acceptance marks an important step toward making this combination therapy available as a first-line treatment for adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). The application is based on results from the CheckMate -8HW study, which showed that the dual immunotherapy provided a significant improvement in progression-free survival compared to standard chemotherapy. With the submission now considered complete, the EMA will begin its centralized review process. This development could offer a new treatment option for patients with MSI-H/dMMR mCRC, a group that typically has limited benefits from conventional chemotherapy.
Read Announcement - Drug:
- Opdivo (nivolumab)
- Announced Date:
- May 6, 2024
- Estimated Event Date Range:
- February 28, 2025 - February 28, 2025
- Target Action Date:
- February 28, 2025
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
The FDA assigned a target action date of February 28, 2025
AI Summary
The FDA has assigned a target action date of February 28, 2025 for Bristol Myers Squibb’s Biologics License Application for a new subcutaneous formulation of Opdivo (nivolumab). This formulation, co-formulated with Halozyme’s recombinant human hyaluronidase, is designed to offer the same treatment benefits as the existing intravenous version while providing greater convenience. Instead of a 30-to-60-minute infusion, patients could receive their treatment via a quick three-to-five-minute injection.
The application is supported by positive data from the Phase 3 CheckMate -67T trial, which showed that the subcutaneous version is not inferior to the intravenous formulation in terms of drug levels, effectiveness, and safety. If approved, this new option may provide improved treatment ease for patients with various cancers. The FDA’s decision is expected around the assigned target date in early 2025.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- May 6, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab)
AI Summary
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application for a new subcutaneous formulation of Opdivo® (nivolumab). The subcutaneous version is co-formulated with Halozyme’s rHuPH20 and is being developed for approved adult, solid tumor indications. In the Phase 3 CheckMate‑67T trial, this formulation demonstrated similar pharmacokinetics, effectiveness, and safety compared to the traditional IV version. If approved, patients could benefit from a much shorter treatment time—receiving an injection that takes only three to five minutes rather than the usual 30 to 60 minutes for an infusion. The FDA has set a target action date of February 28, 2025, making this a key milestone in offering a more convenient treatment option for cancer patients.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- April 26, 2024
- Estimated Event Date Range:
- June 1, 2024 - June 30, 2024
- Target Action Date:
- June 01, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced A decision on the EU marketing authorization is expected by June 2024
AI Summary
Bristol Myers Squibb and Repertoire Immune Medicines have joined forces to create new tolerizing vaccines aimed at treating autoimmune diseases. The collaboration leverages Repertoire’s innovative DECODE™ platform, which maps key T cell interactions, and Bristol Myers Squibb’s expertise in developing and marketing advanced immune therapies. Repertoire will manage early development work while Bristol Myers Squibb takes the lead on later-stage clinical trials, regulatory processes, and commercialization globally. An upfront payment of $65 million has been made to Repertoire, with the potential for up to $1.8 billion in additional milestone payments and tiered royalties.
Importantly, Bristol Myers Squibb announced that a decision on the EU marketing authorization is expected by June 2024. This milestone is critical as it will help shape the future regulatory pathway for these innovative immune medicines, potentially offering new treatment options for patients with autoimmune diseases.
Read Announcement- Drug:
- Opdivo (nivolumab)
- Announced Date:
- April 26, 2024
- Indication:
- Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
Announcement
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
AI Summary
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine. This new recommendation is for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma, marking a significant milestone in the fight against advanced bladder cancer. The recommendation is based on evidence suggesting that the combination therapy may improve the immune system’s ability to target cancer cells, offering a potentially valuable treatment option for patients with limited alternatives.
The news highlights Bristol Myers Squibb’s ongoing commitment to advancing immuno-oncology innovations. The CHMP’s positive assessment underscores the growing role of immune therapies in managing complex cancers and reinforces the company’s focus on developing transformative treatments that can enhance patient outcomes worldwide.
Read Announcement
Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743 FDA Regulatory Timeline and Events
Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743 is a drug developed by Bristol Myers Squibb for the following indication: Unresectable Malignant Pleural Mesothelioma.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743
- Announced Date:
- April 11, 2025
- Indication:
- Unresectable Malignant Pleural Mesothelioma
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo®(nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most common primary liver cancer.
AI Summary
Bristol Myers Squibb announced that the FDA has approved the combination treatment Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line therapy for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most common type of liver cancer. This decision is based on the positive results of the Phase 3 CheckMate-9DW trial. In the study, patients receiving the dual immunotherapy showed a significant overall survival benefit compared to those treated with the standard tyrosine kinase inhibitors lenvatinib or sorafenib. Notably, 38% of patients treated with Opdivo plus Yervoy were alive at three years, compared to 24% in the comparator group. This approval offers a promising new first-line treatment option, addressing a significant unmet need and aiming to improve long-term outcomes for patients battling advanced liver cancer.
Read Announcement- Drug:
- Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743
- Announced Date:
- January 31, 2025
- Indication:
- Unresectable Malignant Pleural Mesothelioma
Announcement
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo®(nivolumab) plus Yervoy®(ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial.
AI Summary
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for first‐line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This recommendation comes after the Phase 3 CheckMate –9DW clinical trial showed statistically significant and clinically meaningful improvement in overall survival. In the trial, patients receiving the combination experienced a median overall survival of 23.7 months compared to 20.6 months with the investigator’s choice of lenvatinib or sorafenib. This positive data suggests that the Opdivo plus Yervoy regimen could provide a valuable new treatment option for patients with advanced liver cancer. The CHMP opinion will now be reviewed by the European Commission for final approval in the EU.
Read Announcement- Drug:
- Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743
- Announced Date:
- December 23, 2024
- Indication:
- Unresectable Malignant Pleural Mesothelioma
Announcement
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab)for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).
AI Summary
Bristol Myers Squibb announced that the European Commission has approved the use of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment for adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). This approval marks the first dual checkpoint inhibitor regimen available in the European Union for treating this subgroup of colorectal cancer patients, who typically do not respond well to conventional chemotherapy.
The decision is supported by results from the Phase 3 CheckMate -8HW trial, which showed a significant reduction in the risk of disease progression or death compared to standard chemotherapy. The approval covers all 27 EU member states as well as Iceland, Liechtenstein, and Norway, underscoring a major advancement in treatment options for patients with this challenging form of colorectal cancer.
Read Announcement- Drug:
- Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743
- Announced Date:
- November 15, 2024
- Indication:
- Unresectable Malignant Pleural Mesothelioma
Announcement
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) plus Yervoy® (ipilimumab)for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). Of significance, the CheckMate -8HW trial results showed reduction in the risk of disease progression or death by 79% (HR: 0.21; 95% CI: 0.14-0.32; p<0.0001) compared to chemotherapy in this patient population.
AI Summary
Bristol Myers Squibb recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first‐line treatment for adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). This recommendation was mainly based on impressive data from the CheckMate -8HW trial where the dual immunotherapy significantly improved progression-free survival. In the trial, the risk of disease progression or death was reduced by 79% compared to chemotherapy. These positive outcomes offer a transformative option for the approximately 5-7% of mCRC patients with MSI-H/dMMR tumors, who often receive little benefit from conventional treatments. The European Commission will now review the recommendation before a final decision is made.
Read Announcement
Opdivo®(nivolumab) plus Yervoy®(ipilimumab) CheckMate -9DW FDA Regulatory Events
Opdivo®(nivolumab) plus Yervoy®(ipilimumab) CheckMate -9DW is a drug developed by Bristol Myers Squibb for the following indication: for the First-Line Treatment of Adult Patients with Unresectable or Advanced Hepatocellular Carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Opdivo®(nivolumab) plus Yervoy®(ipilimumab) CheckMate -9DW
- Announced Date:
- March 7, 2025
- Indication:
- for the First-Line Treatment of Adult Patients with Unresectable or Advanced Hepatocellular Carcinoma
Announcement
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo®(nivolumab) plus Yervoy®(ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC).
AI Summary
Bristol Myers Squibb announced that the European Commission has approved the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first‐line treatment for adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This approval is based on positive results from the Phase 3 CheckMate –9DW clinical trial, which demonstrated a significant improvement in overall survival compared to the current treatments, lenvatinib or sorafenib. The dual immunotherapy approach offers a new option that may extend patients’ lives and addresses an area of high unmet medical need in liver cancer care. This decision means that the treatment is now available in all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway, reinforcing the commitment of Bristol Myers Squibb to improve outcomes for patients with liver cancer.
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Opdualag FDA Regulatory Events
Opdualag is a drug developed by Bristol Myers Squibb for the following indication: For the adjuvant treatment of patients with completely resected stage III-IV melanoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Opdualag
- Announced Date:
- February 13, 2025
- Indication:
- For the adjuvant treatment of patients with completely resected stage III-IV melanoma
Announcement
Bristol Myers Squibb announced the Phase 3 RELATIVITY-098 trial evaluating Opdualag™ (nivolumab and relatlimab-rmbw) for the adjuvant treatment of patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival (RFS).
AI Summary
Bristol Myers Squibb announced that its Phase 3 RELATIVITY‑098 trial of Opdualag™—a fixed-dose combination of nivolumab and relatlimab—did not meet its primary endpoint of recurrence‑free survival (RFS) when used as adjuvant therapy in patients with completely resected stage III‑IV melanoma. Researchers believe the trial’s outcome may be due to insufficient antitumor T cells in patients after tumor removal, which may limit Opdualag’s ability to work at its full potential. Despite the disappointing efficacy result, the safety profile of Opdualag was consistent with what is known for its individual components. The company remains committed to using Opdualag as a standard of care in the first‑line treatment of unresectable or metastatic melanoma while continuing to evaluate its potential in other tumor types.
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Reblozyl (luspatercept-aamt) FDA Regulatory Events
Reblozyl (luspatercept-aamt) is a drug developed by Bristol Myers Squibb for the following indication: Non-transfusion Dependent (NTD) Beta Thalassemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Reblozyl (luspatercept-aamt)
- Announced Date:
- July 18, 2025
- Indication:
- Non-transfusion Dependent (NTD) Beta Thalassemia
Announcement
Bristol Myers Squibb announced the Phase 3 INDEPENDENCE trial evaluating Reblozyl®(luspatercept-aamt) with concomitant janus kinase inhibitor (JAKi) therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell (RBC) transfusions did not meet its primary endpoint of RBC transfusion independence during any consecutive 12-week period, starting within the first 24 weeks of treatment, compared to placebo (p=0.0674).
AI Summary
Bristol Myers Squibb announced new results from the Phase 3 INDEPENDENCE trial, which tested Reblozyl® (luspatercept-aamt) combined with a janus kinase inhibitor in adult patients suffering from myelofibrosis-associated anemia who require red blood cell transfusions. The trial’s primary goal—achieving full red blood cell transfusion independence for any consecutive 12-week period within the first 24 weeks—was not met compared to placebo (p=0.0674). Despite this, patients receiving Reblozyl showed a numerical and clinically meaningful improvement, in line with earlier Phase 2 results. Important secondary endpoints also favored Reblozyl, with more patients experiencing at least a 50% reduction in their transfusion burden and notable increases in hemoglobin levels while remaining transfusion independent for 12 consecutive weeks. These findings offer promising signs for improving care in myelofibrosis-associated anemia and will guide further discussions with regulatory agencies.
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Repotrectinib FDA Regulatory Timeline and Events
Repotrectinib is a drug developed by Bristol Myers Squibb for the following indication: NTRK Fusion-Positive Advanced Solid Tumors.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Repotrectinib
- Announced Date:
- April 21, 2025
- Indication:
- NTRK Fusion-Positive Advanced Solid Tumors
Announcement
Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for repotrectinib for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
AI Summary
Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has accepted its supplemental New Drug Application (sNDA) for repotrectinib. This application is specifically for treating adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The treatment target includes patients with locally advanced or metastatic disease, where surgery might cause severe complications, and those who have not responded to previous therapies or lack other effective treatment options.
According to Zai Lab, patients with NTRK fusion-positive tumors face significant challenges, especially when they develop resistance to current tyrosine kinase inhibitors. With no approved therapies for both TKI-naïve and TKI-pretreated patients in China, repotrectinib is seen as a promising next-generation option that may improve treatment outcomes and provide a much-needed advancement in addressing these aggressive cancers.
Read Announcement- Drug:
- Repotrectinib
- Announced Date:
- November 15, 2024
- Indication:
- NTRK Fusion-Positive Advanced Solid Tumors
Announcement
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI), as a treatment for adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
AI Summary
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended repotrectinib for approval. This next-generation tyrosine kinase inhibitor (TKI) is designed to treat adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and patients aged 12 and older with advanced solid tumors that express an NTRK gene fusion. The recommendation covers patients who have already received a prior NTRK inhibitor, as well as those who have not received one when alternative treatment options provide limited clinical benefit or have been exhausted.
The positive opinion was based on data from the TRIDENT-1 and CARE trials, which demonstrated strong, durable responses in these patient groups. The European Commission (EC) will now review the CHMP recommendation, with a final decision expected in January 2025.
Read Announcement- Drug:
- Repotrectinib
- Announced Date:
- June 13, 2024
- Indication:
- NTRK Fusion-Positive Advanced Solid Tumors
Announcement
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro™ (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
AI Summary
Bristol Myers Squibb announced that the FDA has granted accelerated approval for Augtyro™ (repotrectinib). This approval is for treating adult and pediatric patients 12 years of age and older who have solid tumors with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. These patients include those with locally advanced or metastatic tumors or cases where surgery could lead to severe complications, and whose cancers have progressed following prior treatments or have no other satisfactory options.
The decision was based on encouraging overall response rates and duration of response seen in the Phase 1/2 TRIDENT-1 trial. This trial evaluated Augtyro in patients whether or not they had been previously treated with tyrosine kinase inhibitors (TKIs), thereby expanding the targeted treatment options available for patients with NTRK-positive tumors.
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Zeposia (Ozanimod) FDA Regulatory Events
Zeposia (Ozanimod) is a drug developed by Bristol Myers Squibb for the following indication: Active Ulcerative Colitis (UC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Zeposia (Ozanimod)
- Announced Date:
- September 18, 2024
- Indication:
- Active Ulcerative Colitis (UC)
Announcement
Bristol Myers Squibb announced new data from the Phase 3 DAYBREAK trial demonstrating that decreased rates of brain volume loss were sustained in the open-label extension (OLE) for patients treated with Zeposia (ozanimod) for relapsing forms of multiple sclerosis.
AI Summary
Bristol Myers Squibb recently revealed new Phase 3 DAYBREAK trial results, showing that continuous treatment with Zeposia (ozanimod) helps to sustain reduced rates of brain volume loss in patients with relapsing forms of multiple sclerosis. In the open-label extension of the trial, patients treated with Zeposia for up to five years maintained consistently low annualized rates of whole brain volume loss, with figures around −0.27% to −0.35% from baseline. These findings indicate that long-term use of Zeposia may protect brain tissue and potentially slow down the progression of multiple sclerosis-related damage. The sustained reduction in brain volume loss adds important evidence to Zeposia’s profile as an effective oral therapy, supporting its role in managing neurodegeneration in relapsing MS patients over extended periods.
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