This section highlights FDA-related milestones and regulatory updates for drugs developed by Genmab A/S (GMAB).
Over the past two years, Genmab A/S has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Rina-S, epcoritamab, epcoritamab-bysp, EPKINLY®, TIVDAK, Epcoritamab, and TEPKINLY. 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.
Rina-S FDA Regulatory Timeline and Events
Rina-S is a drug developed by Genmab A/S for the following indication: In Heavily Pretreated Patients with Ovarian and Endometrial Cancers.
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:
- Rina-S
- Announced Date:
- April 13, 2026
- Indication:
- In Heavily Pretreated Patients with Ovarian and Endometrial Cancers
Announcement
Genmab A/S announced today new datademonstrating thatrinatabart sesutecan (Rina-S®), an investigational folate receptor alpha (FRα)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC), evaluated in combination with bevacizumab in patients withadvanced ovarian cancer, showed a safety profile consistent with the known safety profiles of Rina-S and bevacizumab.
AI Summary
Genmab A/S announced new data demonstrating that Rinatabart sesutecan (Rina‑S®), an investigational folate receptor alpha (FRα)‑targeted, topoisomerase I (TOPO1)‑inhibitor antibody‑drug conjugate (ADC), evaluated in combination with bevacizumab in patients with advanced ovarian cancer, showed a safety profile consistent with the known safety profiles of Rina‑S and bevacizumab. The company reported that no unexpected safety signals emerged when the agents were given together.
These results suggest the combination’s side effects were predictable and manageable based on prior experience with each drug, supporting continued clinical development. The data provide reassurance about tolerability as researchers further assess how well the combination controls disease and how it might be used in future studies. Genmab said additional analyses and ongoing trials will help clarify benefits and risks in this patient population.
Read Announcement- Drug:
- Rina-S
- Announced Date:
- October 18, 2025
- Indication:
- In Heavily Pretreated Patients with Ovarian and Endometrial Cancers
Announcement
Genmab A/S announced today updated data from cohort B2 of the Phase 1/2 RAINFOL™-01 trial evaluating rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha (FRα)-targeted, TOPO1-inhibitor antibody-drug conjugate (ADC).
AI Summary
Genmab A/S announced updated results from cohort B2 of the Phase 1/2 RAINFOL™-01 trial evaluating the antibody-drug conjugate rinatabart sesutecan (Rina-S®) in advanced endometrial cancer. In heavily pretreated patients with prior platinum chemotherapy and immune checkpoint inhibitor treatment, Rina-S at 100 mg/m2 achieved a 50.0% confirmed objective response rate, including two complete responses, regardless of folate receptor α expression.
At a median follow-up of one year, 63.6% of responders maintained their anti-tumor responses and continue therapy. Patients had received a median of three prior lines of treatment, highlighting activity in a difficult-to-treat population.
The safety profile was manageable, with most adverse events being cytopenias and low-grade gastrointestinal symptoms. There were no signals of ocular toxicity, neuropathy, or interstitial lung disease. Grade 3 or higher events occurred in 36.4% of patients at 100 mg/m2 but rarely led to discontinuation.
A randomized Phase 3 trial (RAINFOL-03) in advanced endometrial cancer is now underway to confirm the efficacy and safety of Rina-S.
Read Announcement- Drug:
- Rina-S
- Announced Date:
- August 26, 2025
- Indication:
- In Heavily Pretreated Patients with Ovarian and Endometrial Cancers
Announcement
Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha (FRα)-directed, TOPO1-inhibitor antibody-drug conjugate (ADC), for the treatment of adult patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy.
AI Summary
Genmab A/S announced that the U.S. Food and Drug Administration has awarded Breakthrough Therapy Designation to Rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha–targeted antibody-drug conjugate. This designation applies to adult patients with recurrent or progressive endometrial cancer whose disease progressed after prior platinum-based chemotherapy and PD-(L)1 therapy. The FDA’s decision was supported by data from the Phase 1/2 RAINFOL™-01 trial, where heavily pretreated patients demonstrated encouraging response rates in the dose-expansion cohort.
Rina-S development will accelerate, with ongoing evaluation as a single agent in RAINFOL-01 and a planned Phase 3 trial in endometrial cancer. The ADC combines a novel TOPO1-inhibitor payload with an FRα-directed monoclonal antibody and is also under study in ovarian cancer and other solid tumors. This designation highlights Rina-S’s potential to address unmet needs in advanced endometrial cancer.
Read Announcement- Drug:
- Rina-S
- Announced Date:
- June 2, 2025
- Indication:
- In Heavily Pretreated Patients with Ovarian and Endometrial Cancers
Announcement
Genmab A/S announced new data from cohort B2 of the Phase 1/2 RAINFOL™-01 trial evaluating rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha(FRα)-targeted, TOPO1-inhibitor antibody-drug conjugate (ADC).
AI Summary
Genmab A/S announced new data from cohort B2 of the Phase 1/2 RAINFOL™-01 trial evaluating rinatabart sesutecan (Rina-S®), an investigational antibody-drug conjugate that targets the folate receptor alpha (FRα) and carries a topoisomerase I inhibitor. In this cohort of heavily pretreated advanced endometrial cancer patients, Rina-S administered at 100 mg/m² every three weeks resulted in a confirmed objective response rate (ORR) of 50%, which included two complete responses. The median duration of response was not reached after a median follow-up of 7.7 months.
The encouraging results are prompting continued evaluation of single-agent Rina-S in a Phase 2 trial, with plans to further assess the treatment in a Phase 3 trial. These results offer hope for new treatment options for patients with advanced and recurrent endometrial cancer.
Read Announcement- Drug:
- Rina-S
- Announced Date:
- May 22, 2025
- Indication:
- In Heavily Pretreated Patients with Ovarian and Endometrial Cancers
Announcement
Genmab A/S announced that it will present new research from its comprehensive development program evaluating its late-stage portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 to June 3 in Chicago, Illinois.
AI Summary
Genmab A/S announced that it will unveil new research from its comprehensive development program at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The event is scheduled from May 30 to June 3 in Chicago, Illinois. Genmab will present important findings from its late-stage portfolio, underlining its commitment to advancing innovative cancer treatments.
One of the key highlights is the first disclosure of results from a Phase 1/2 trial evaluating rinatabart sesutecan (Rina-S®) in patients with recurrent or advanced endometrial cancer. In addition, Genmab will share long-term follow-up data from the EPCORE™ NHL-1 study, which examines epcoritamab, a bispecific antibody targeting B-cell cancers. These presentations aim to provide new insights into therapies that address challenging cancer cases and bring fresh hope to patients in need of alternative treatment options.
Read Announcement- Drug:
- Rina-S
- Announced Date:
- March 17, 2025
- Indication:
- In Heavily Pretreated Patients with Ovarian and Endometrial Cancers
Announcement
Genmab A/S announced today updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S®), an investigational folate receptor-alpha (FRα)-targeted, TOPO1 antibody-drug conjugate (ADC) that showed Rina-S 120 mg/m2 every 3 weeks (Q3W) resulted in a confirmed objective response rate (ORR) of 55.6% (95% CI: 30.8-78.5) in heavily pre-treated ovarian cancer (OC) patients regardless of FRα expression levels.
AI Summary
Genmab A/S announced updated data from cohort B1 of the Phase 1/2 RAINFOL-01 trial for its investigational treatment Rina-S® (rinatabart sesutecan). Rina-S is a folate receptor‐alpha targeted, TOPO1 antibody-drug conjugate. The study focused on heavily pre-treated ovarian cancer patients, and results showed that the 120 mg/m² dose given every three weeks achieved a confirmed objective response rate (ORR) of 55.6% (95% CI: 30.8-78.5). With a median follow-up of 48 weeks, the median duration of response has not yet been reached, highlighting the promise of the treatment even in advanced cases.
This encouraging antitumor activity was seen regardless of FRα expression levels. The data from the dose expansion cohort add to the potential for Rina-S to offer a new treatment option in ovarian cancer, addressing a significant medical need in patients with platinum-resistant disease.
Read Announcement- Drug:
- Rina-S
- Announced Date:
- September 15, 2024
- Indication:
- In Heavily Pretreated Patients with Ovarian and Endometrial Cancers
Announcement
Genmab A/S new data from the Phase 1/2 study of rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha (FRα)-targeted, Topo1 antibody-drug conjugate (ADC), demonstrated a confirmed objective response rate (ORR) of 50.0% (95% CI) in ovarian cancer patients treated with Rina-S 120 mg/m2 once every 3 weeks (Q3W), regardless of FRα expression levels.
AI Summary
Genmab A/S recently unveiled promising Phase 1/2 data for rinatabart sesutecan (Rina-S), an investigational Topo1 antibody-drug conjugate that targets the folate receptor‐alpha (FRα). In the dose expansion cohort, ovarian cancer patients treated with Rina-S at 120 mg/m² every three weeks achieved a confirmed objective response rate of 50%, regardless of their FRα expression levels. This result is particularly significant for heavily pretreated patients with advanced ovarian cancer, a group with limited treatment alternatives. The study’s encouraging outcomes support the further evaluation of the 120 mg/m² dose in an upcoming Phase 3 trial aimed at assessing both safety and efficacy. These findings highlight the potential of Rina-S as a new therapeutic option for ovarian cancer, offering hope for patients who have not found success with existing treatments.
Read Announcement
Epcoritamab FDA Regulatory Timeline and Events
Epcoritamab is a drug developed by Genmab A/S for the following indication: To-Treat Relapsed/Refractory Follicular Lymphoma.
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:
- epcoritamab
- Announced Date:
- January 16, 2026
- Indication:
- To-Treat Relapsed/Refractory Follicular Lymphoma
Announcement
Genmab A/S announced topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, which demonstrated an improvement in progression-free survival (PFS) (HR: 0.74 [95% CI 0.60 to 0.92])* in patients treated with epcoritamab monotherapy.
AI Summary
Genmab reported topline Phase 3 results from the EPCORE DLBCL-1 trial showing that epcoritamab, a subcutaneous CD3xCD20 T-cell engaging bispecific antibody, improved progression-free survival (PFS) compared with investigator’s choice chemotherapy (HR 0.74; 95% CI 0.60–0.92) when given as monotherapy in patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL). The trial also showed higher complete response rates, longer duration of response, and delayed time to next treatment with epcoritamab.
The global study enrolled 483 patients who had at least one prior therapy and were ineligible for high‑dose chemo and stem cell transplant; comparators were R‑GemOx or BR. Overall survival did not reach statistical significance (HR 0.96; 95% CI 0.77–1.20). Adverse events were consistent with the known safety profile. Genmab and partner AbbVie will engage global regulators to discuss next steps and further analyses are ongoing. Additional Phase 3 data are expected in 2026.
Read Announcement- Drug:
- epcoritamab
- Announced Date:
- December 6, 2025
- Indication:
- To-Treat Relapsed/Refractory Follicular Lymphoma
Announcement
Genmab A/S announced updated results from two ongoing clinical trials evaluating the efficacy and safety of epcoritamab-bysp, a T-cell engaging antibody administered subcutaneously, as a monotherapy and in combination with other standard of care treatments in adult patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).
AI Summary
Genmab A/S reported updated results from two ongoing trials of epcoritamab-bysp, a subcutaneous T‑cell engaging bispecific antibody that binds CD3 on T cells and CD20 on B cells. The programs include studies of epcoritamab as a monotherapy in diffuse large B‑cell lymphoma (DLBCL) and as a combination therapy with rituximab and lenalidomide (R2) in follicular lymphoma (FL).
In the pivotal Phase 3 EPCORE FL‑1 trial in relapsed or refractory FL, fixed‑duration epcoritamab plus R2 reduced the risk of disease progression or death by 79% versus R2 alone (HR 0.21; p<0.0001). Overall response rate was 95% versus 79%, and complete response rates were 83% versus 50%. The 12‑month duration of response was 89% with the combination versus 49% with R2.
Safety for epcoritamab + R2 matched known profiles: higher rates of Grade 3–4 adverse events (mainly neutropenia and infections) and low‑grade cytokine release syndrome in about 26% of patients. The DLBCL monotherapy trial remains ongoing.Read Announcement
- Drug:
- epcoritamab
- Announced Date:
- September 3, 2025
- Indication:
- To-Treat Relapsed/Refractory Follicular Lymphoma
Announcement
AbbVie announced updated results from the Phase 2 EPCORE® NHL-6 trial (NCT05451810) evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy.
AI Summary
AbbVie’s Phase 2 EPCORE® NHL-6 trial tested whether the first full 48 mg dose of epcoritamab, a subcutaneous T-cell engaging bispecific antibody, can be given and watched safely in an outpatient clinic. Among 88 adults with relapsed or refractory diffuse large B-cell lymphoma who had at least one prior therapy, 81 (92%) received their first full dose without hospital admission. Cytokine release syndrome (CRS) occurred in 40.2% of patients, was mostly mild (Grade 1-2), resolved in two days on average, and did not force anyone to stop treatment. Immune cell-associated neurotoxicity syndrome (ICANS) appeared in 7.6% of patients, was also mild, resolved in three days on average, and did not lead to treatment withdrawal.
These findings support giving epcoritamab outside the hospital and could expand access to this therapy. The study’s safety results match earlier trials, suggesting that outpatient dosing of epcoritamab is feasible and well tolerated for patients with relapsed/refractory DLBCL.
Read Announcement- Drug:
- epcoritamab
- Announced Date:
- June 15, 2025
- Indication:
- To-Treat Relapsed/Refractory Follicular Lymphoma
Announcement
Genmab A/S announced new results from the Phase 1b/2 EPCORE® NHL-2 trial Arm 10 (NCT04663347), evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who are eligible for autologous stem cell transplantation (ASCT).
AI Summary
Genmab A/S announced promising new results from the Phase 1b/2 EPCORE® NHL-2 trial Arm 10. This study evaluated epcoritamab—a T-cell engaging bispecific antibody given by subcutaneous injection—in combination with the R-ICE regimen (rituximab, ifosfamide, carboplatin, and etoposide) in adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who are eligible for autologous stem cell transplantation (ASCT). The trial reported an overall response rate of 87% and a complete response rate of 65%, with 65% of patients moving on to ASCT. The combination therapy was generally well tolerated, with most cases of cytokine release syndrome being low grade and no treatment discontinuations due to adverse events. These encouraging findings suggest that adding epcoritamab to standard salvage chemoimmunotherapy may provide an effective new treatment option for high-risk R/R DLBCL patients.
Read Announcement- Drug:
- epcoritamab
- Announced Date:
- December 8, 2024
- Indication:
- To-Treat Relapsed/Refractory Follicular Lymphoma
Announcement
Genmab A/S announced results from the Phase 1b/2 EPCORE® CLL-1 clinical trial evaluating epcoritamab (Abstract #883), a T-cell engaging bispecific antibody administered subcutaneously, demonstrated an overall response rate (ORR) of 61 percent and a complete response (CR) rate of 39 percent in difficult-to-treat adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) treated with epcoritamab monotherapy.
AI Summary
Genmab A/S announced promising results from its Phase 1b/2 EPCORE® CLL-1 clinical trial evaluating epcoritamab, a T-cell engaging bispecific antibody given by subcutaneous injection. The study focused on difficult-to-treat adult patients with relapsed or refractory chronic lymphocytic leukemia who had already received multiple previous therapies. Epcoritamab monotherapy achieved an overall response rate of 61 percent, with a complete response rate of 39 percent. The median time to any response was two months, and the median time to a complete response was 5.6 months.
Notably, among evaluable responders, 75 percent reached undetectable minimal residual disease, indicating a strong treatment effect. These encouraging results support the potential of epcoritamab to offer an effective treatment option for high-risk patients in need of new therapeutic strategies.
Read Announcement- Drug:
- epcoritamab
- Announced Date:
- December 7, 2024
- Indication:
- To-Treat Relapsed/Refractory Follicular Lymphoma
Announcement
Genmab A/S announced new results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating fixed-duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, plus lenalidomide + rituximab (R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
AI Summary
Genmab A/S announced promising new results from its Phase 1b/2 EPCORE® NHL-2 trial in adult patients with relapsed or refractory follicular lymphoma. The study evaluated a fixed-duration treatment combining epcoritamab—a T-cell engaging bispecific antibody given via subcutaneous injection—with lenalidomide and rituximab (R2). This combination aims to boost the immune system’s ability to target and kill cancer cells while overcoming resistance to previous treatments. The trial’s design focuses on delivering a defined treatment schedule, potentially improving patient convenience and outcomes. These early results highlight the potential of epcoritamab in combination with R2 to offer an effective therapeutic option for patients with difficult-to-treat FL. Genmab is continuing to explore the use of epcoritamab across various B-cell malignancies, further supporting its role in advancing cancer care with innovative immunotherapy approaches.
Read Announcement- Drug:
- epcoritamab
- Announced Date:
- May 23, 2024
- Indication:
- To-Treat Relapsed/Refractory Follicular Lymphoma
Announcement
Genmab A/S announced that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, tisotumab vedotin, an antibody-drug conjugate (ADC), and acasunlimab (also known as GEN1046/BNT311), an investigational bispecific antibody, will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL and virtually, May 31-June 2, 2024.
AI Summary
Genmab A/S announced that several abstracts will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL and also available online from May 31 to June 2, 2024. The abstracts include evaluations of epcoritamab, a subcutaneously administered T-cell engaging bispecific antibody, which is being studied in patients with challenging lymphomas. Other presentations will cover tisotumab vedotin, an antibody-drug conjugate (ADC) being tested in patients with head and neck squamous cell carcinoma and recurrent or metastatic cervical cancer, and acasunlimab (also known as GEN1046/BNT311), an investigational bispecific antibody, now being assessed in patients with previously treated metastatic non-small cell lung cancer. These presentations highlight Genmab’s progress in developing novel antibody therapies that aim to improve outcomes for cancer patients.
Read Announcement
Epcoritamab-bysp FDA Regulatory Events
Epcoritamab-bysp is a drug developed by Genmab A/S for the following indication: for follicular lymphoma indications.
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:
- epcoritamab-bysp
- Announced Date:
- December 8, 2025
- Indication:
- for follicular lymphoma indications
Announcement
Genmab A/S announced new and updated data from three arms of the ongoing Phase 1b/2 EPCORE® CLL-1 trial (NCT04623541) evaluating the efficacy and safety of epcoritamab-bysp, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy and in combination for the treatment of patients with Richter transformation (RT), a rare complication in which chronic lymphocytic leukemia (CLL) evolves into an aggressive lymphoma, most often diffuse large B-cell lymphoma (DLBCL).
AI Summary
Genmab announced updated Phase 1b/2 EPCORE CLL-1 data evaluating subcutaneous epcoritamab, a T‑cell‑engaging bispecific antibody, in patients with Richter transformation (RT). In Arm 2A (monotherapy, n=42, median follow‑up 22.9 months) first‑line patients had an overall response rate (ORR) of 57% and complete response (CR) 52%; median overall survival (OS) was 27.5 months and median progression‑free survival (PFS) 8.5 months. Later‑line monotherapy produced lower responses (ORR 38%, CR 29%).
Combination regimens showed higher response rates: Arm 2B (epcoritamab + lenalidomide, n=11) had ORR 82% and CR 73% (median follow‑up 16.7 months), while Arm 2C (epcoritamab + R‑CHOP, n=30) had ORR 77% and CR 63% (median follow‑up 13.6 months). Safety findings were consistent with expected profiles: cytokine release syndrome was common (mostly Grade 1–2), immune neurotoxicity occurred in some patients, and cytopenias and infections were frequent. Results suggest epcoritamab, alone or in combination, may be a promising option for RT and warrant further study.Read Announcement
- Drug:
- epcoritamab-bysp
- Announced Date:
- November 18, 2025
- Indication:
- for follicular lymphoma indications
Announcement
the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL).
Read Announcement
EPKINLY® (epcoritamab-bysp) FDA Regulatory Timeline and Events
EPKINLY® (epcoritamab-bysp) is a drug developed by Genmab A/S for the following indication: To Treat Patients with Relapsed or Refractory Follicular Lymphoma.
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:
- EPKINLY® (epcoritamab-bysp)
- Announced Date:
- December 7, 2025
- Indication:
- To Treat Patients with Relapsed or Refractory Follicular Lymphoma
Announcement
Genmab A/S announced primary data from the pivotal Phase 3 EPCORE® FL-1 study evaluating fixed duration EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
AI Summary
Genmab reported primary results from the Phase 3 EPCORE FL-1 trial testing fixed‑duration epcoritamab (EPKINLY) combined with rituximab and lenalidomide (EPKINLY + R2) versus R2 alone in adults with relapsed or refractory follicular lymphoma. The randomized study enrolled 243 patients to the combination and 245 to R2, with a median follow‑up of 14.8 months. Dual primary endpoints included progression‑free survival (PFS) and overall response rate (ORR) assessed by an independent review committee.
The trial found a 79% reduction in risk of disease progression or death with EPKINLY + R2 (HR 0.21; 95% CI 0.14–0.31; p<0.0001). ORR was 95% versus 79% for R2 (p<0.0001). Complete response rates were 83% versus 50%, and 12‑month duration of response was 89% versus 49% for the combination and R2, respectively.
Safety was consistent with known profiles. Grade 3–4 adverse events occurred in 90.1% versus 67.6%, mainly more neutropenia (68.7% vs 42.0%) and infections (33.3% vs 15.1%). Fatal events were 1.6% versus 3.8%. Cytokine release syndrome was mostly low grade (26.3%; 21.2% Grade 1, 5.3% Grade 2). Results were presented at ASH and published in The Lancet.
Read Announcement- Drug:
- EPKINLY® (epcoritamab-bysp)
- Announced Date:
- February 20, 2025
- Indication:
- To Treat Patients with Relapsed or Refractory Follicular Lymphoma
Announcement
Genmab A/S that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY® (epcoritamab) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL; Grades 1 to 3A) who have received two or more prior lines of therapy.
AI Summary
Genmab A/S announced that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY® (epcoritamab) for treating patients with relapsed or refractory follicular lymphoma (Grades 1 to 3A) who have had two or more prior therapies. This approval marks a significant milestone as EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously to be approved in Japan for both R/R follicular lymphoma and R/R large B-cell lymphomas. This dual indication aims to address the high unmet need for effective treatments among patients whose cancer returns or stops responding to current therapies. The approval was based on positive clinical data from Phase 1/2 trials, where lasting responses and manageable side effects were observed, highlighting EPKINLY’s potential as an important option for patients facing limited treatment alternatives.
Read Announcement- Drug:
- EPKINLY® (epcoritamab-bysp)
- Announced Date:
- August 15, 2024
- Indication:
- To Treat Patients with Relapsed or Refractory Follicular Lymphoma
Announcement
AbbVie announced that EPKINLY is now listed on the Ontario Health (Cancer Care Ontario) formulary under the NDFP (New Drug Funding Program) and the HCTFP (High Cost Therapy Funding Program) programs1 and the Régie de l'assurance maladie du Québec (RAMQ) Liste des médicaments - Établissements2 for the treatment of adult patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) after two or more lines of systemic therapy and who have previously received or are unable to receive CAR-T cell therapy.
AI Summary
AbbVie has announced that its cancer therapy EPKINLY is now included on the Ontario Health (Cancer Care Ontario) formulary under the New Drug Funding Program (NDFP) and the High Cost Therapy Funding Program (HCTFP). It is also listed on the Régie de l'assurance maladie du Québec’s (RAMQ) Liste des médicaments – Établissements. This inclusion provides new access for adult patients who have Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL).
These patients must have undergone two or more lines of systemic therapy and either previously received or be unable to receive CAR-T cell therapy. The decision to list EPKINLY on these formularies aims to give more patients an effective treatment option for this aggressive form of lymphoma, potentially improving their outcomes with a targeted immunotherapy approach.
Read Announcement- Drug:
- EPKINLY® (epcoritamab-bysp)
- Announced Date:
- June 26, 2024
- Indication:
- To Treat Patients with Relapsed or Refractory Follicular Lymphoma
Announcement
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy.
AI Summary
AbbVie announced that the FDA has approved EPKINLY® (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody given by subcutaneous injection for adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of prior therapy. This Accelerated Approval is based on data showing strong overall response rates and durable patient responses. The approval marks a significant step for patients with FL, a form of non-Hodgkin’s lymphoma that is typically incurable using current treatments, leaving many with limited options after relapse.
EPKINLY’s subcutaneous dosing offers a convenient alternative as it can be administered outside of a hospital setting using a 3-step dosing regimen, which helps manage side effects like cytokine release syndrome. AbbVie believes this treatment could become a core option for multiple B-cell cancers moving forward.
Read Announcement
TIVDAK FDA Regulatory Events
TIVDAK is a drug developed by Genmab A/S for the following indication: For Patients with Recurrent or Metastatic Cervical Cancer.
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:
- TIVDAK
- Announced Date:
- March 31, 2025
- Indication:
- For Patients with Recurrent or Metastatic Cervical Cancer
Announcement
Genmab A/S announced today that the European Commission (EC) has granted marketing authorization for TIVDAK® (tisotumab vedotin), an antibody-drug conjugate (ADC), as monotherapy treatment for adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
AI Summary
Genmab A/S announced that the European Commission has granted marketing authorization for TIVDAK® (tisotumab vedotin) as a monotherapy treatment for adult patients with recurrent or metastatic cervical cancer who have experienced disease progression after systemic therapy. This approval marks a significant advancement, as TIVDAK is the first and only antibody-drug conjugate (ADC) approved in the EU for this challenging condition.
Clinical data from the global Phase 3 innovaTV 301 trial showed that TIVDAK led to superior overall survival compared to chemotherapy. The results, including improvements in progression-free survival and response rates, support TIVDAK’s potential to become a new standard of care for advanced cervical cancer. This milestone offers new hope for patients facing limited treatment options and underscores ongoing progress in targeted cancer therapies.
Read Announcement- Drug:
- TIVDAK
- Announced Date:
- January 15, 2025
- Indication:
- For Patients with Recurrent or Metastatic Cervical Cancer
Announcement
Zai Lab Limited announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, demonstrating a clinically meaningful improvement in overall survival with TIVDAK treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.
AI Summary
Zai Lab Limited recently announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study. In this study, TIVDAK treatment showed a clinically meaningful improvement in overall survival compared to chemotherapy among patients with previously treated recurrent or metastatic cervical cancer. The findings include a 45% reduction in the risk of death, and secondary measures like progression-free survival and objective response rate also favored TIVDAK over standard chemotherapy.
The safety profile in the China subpopulation was manageable and consistent with results seen in the broader global study. These promising results support TIVDAK as a potential new treatment option for a patient group with limited effective therapies. Zai Lab plans to submit a New Drug Application to China’s National Medical Products Administration in the first quarter of 2025, and will leverage its existing commercial presence with ZEJULA in women’s cancer to improve patient access if approved.
Read Announcement
Epcoritamab (DuoBody-CD3xCD20) FDA Regulatory Events
Epcoritamab (DuoBody-CD3xCD20) is a drug developed by Genmab A/S for the following indication: Follicular Lymphoma (FL).
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:
- Epcoritamab (DuoBody-CD3xCD20)
- Announced Date:
- December 7, 2024
- Indication:
- Follicular Lymphoma (FL)
Announcement
AbbVie announced updated results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating fixed-duration investigational epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, plus lenalidomide + rituximab (R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
AI Summary
AbbVie recently announced updated findings from the Phase 1b/2 EPCORE® NHL-2 trial, which looked at a new treatment option for adults with relapsed or refractory follicular lymphoma. The trial evaluated a fixed-duration dosing regimen of investigational epcoritamab—a CD3xCD20 bispecific T-cell-engaging antibody delivered subcutaneously—in combination with lenalidomide and rituximab (R2). Results showed impressive outcomes, with an overall response rate of 96% and a complete response rate of 87% among 111 patients over a median follow-up of more than two years. Additionally, 89% of patients who achieved a complete response maintained it at 18 months. These encouraging results support the further evaluation of this combination therapy in an ongoing Phase 3 trial and highlight its potential to offer a durable treatment alternative for patients with follicular lymphoma.
Read Announcement- Drug:
- Epcoritamab (DuoBody-CD3xCD20)
- Announced Date:
- June 2, 2024
- Indication:
- Follicular Lymphoma (FL)
Announcement
Genmab A/S announced new efficacy and safetydata from two ongoing Phase 1/2 clinical trials evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with certain types of follicular lymphoma (FL).
AI Summary
Genmab A/S recently announced new efficacy and safety data from two ongoing Phase 1/2 clinical trials evaluating epcoritamab, a T-cell engaging bispecific antibody given by subcutaneous injection. In the EPCORE™ NHL-2 study, patients with previously untreated follicular lymphoma treated with epcoritamab in combination with rituximab-lenalidomide showed a 95% overall response rate and an 85% complete response rate. This data highlights the potential of a chemotherapy-free option for first-line treatment in this patient group.
In another trial, the EPCORE™ NHL-1 study, researchers focused on optimizing dosing by introducing mitigation strategies for cytokine release syndrome (CRS) and neurotoxicity. These strategies resulted in a significant reduction of CRS incidence, with no severe cases reported. Overall, these findings support further evaluation of epcoritamab as a promising treatment option for certain types of follicular lymphoma.
Read Announcement
TEPKINLY FDA Regulatory Events
TEPKINLY is a drug developed by Genmab A/S for the following indication: For the Treatment of Adults with Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL).
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:
- TEPKINLY
- Announced Date:
- June 28, 2024
- Indication:
- For the Treatment of Adults with Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
Announcement
AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional marketing authorization of epcoritamab (TEPKINLY®), the first and only T-cell engaging bispecific antibody administered subcutaneously (under the skin), as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more prior therapies.
AI Summary
AbbVie announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the conditional marketing authorization of epcoritamab (TEPKINLY®). This approval is based on data from the Phase 1/2 EPCORE® NHL-1 study and is significant because epcoritamab is the first and only T-cell engaging bispecific antibody administered subcutaneously as a monotherapy for treating adults with relapsed or refractory follicular lymphoma (FL) after at least two previous therapies. The CHMP decision addresses an unmet need for FL patients in the European Union who often face disease recurrence and diminishing responses with each treatment line. AbbVie and Genmab are co-developing the drug, and the European Commission’s final decision on this indication is expected later this year.
Read Announcement
Tisotumab Vedotin FDA Regulatory Events
Tisotumab Vedotin is a drug developed by Genmab A/S for the following indication: Recurrent or Metastatic Cervical Cancer.
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:
- Tisotumab Vedotin
- Announced Date:
- June 3, 2024
- Indication:
- Recurrent or Metastatic Cervical Cancer
Announcement
Genmab A/S announced today that data from the Phase 2 innovaTV 207 trial (NCT03485209) Part C (n=40), investigating tisotumab vedotin, an antibody-drug conjugate directed to tissue factor, demonstrated encouraging antitumor activity as a monotherapy in patients with head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on or after first-line therapy.
AI Summary
Genmab A/S reported encouraging results from Part C of its Phase 2 innovaTV 207 trial (NCT03485209) investigating tisotumab vedotin, an antibody‐drug conjugate, in patients with head and neck squamous cell carcinoma (HNSCC). In this trial, 40 patients who experienced disease progression after first-line therapy received tisotumab vedotin monotherapy. The study demonstrated a confirmed objective response rate of 32.5%, with one patient achieving a complete response and 12 showing a partial response. The median duration of response was 5.6 months, and many patients saw a response as early as 1.4 months. These promising findings were presented at the 2024 ASCO® Annual Meeting in Chicago and suggest that tisotumab vedotin could provide a potential new treatment option for HNSCC patients after standard platinum-based therapy has failed.
Read Announcement
