This section highlights FDA-related milestones and regulatory updates for drugs developed by BeOne Medicines (ONC).
Over the past two years, BeOne Medicines has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
sonrotoclax, HERIZON-GEA-01, BGB-B2033, Tislelizumab, and BRUKINSA®. 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.
Sonrotoclax FDA Regulatory Timeline and Events
Sonrotoclax is a drug developed by BeOne Medicines for the following indication: Relapsed or Refractory Mantle Cell Lymphoma (MCL).
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:
- sonrotoclax
- Announced Date:
- May 13, 2026
- Indication:
- Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Announcement
BeOne Medicines Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BEQALZI™ (bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.
AI Summary
BeOne Medicines said the U.S. Food and Drug Administration has granted accelerated approval to BEQALZI (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma who have already received at least two systemic treatments, including a BTK inhibitor. BEQALZI is a next-generation BCL2 inhibitor designed to be more potent and selective, with the goal of improving treatment results, safety, and convenience.
The company said this is the first new BCL2 inhibitor approved in the United States in 10 years and the only BCL2 inhibitor approved for mantle cell lymphoma. BeOne said the approval is an important step for patients with this hard-to-treat cancer, especially after BTK inhibitor therapy. The approval was based on response rate and how long responses lasted, and continued approval will depend on future confirmatory trial results. The most common side effects included pneumonia and fatigue.
Read Announcement- Drug:
- sonrotoclax
- Announced Date:
- December 7, 2025
- Indication:
- Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Announcement
BeOne Medicines Ltd announced new data on sonrotoclax, a next-generation investigational BCL2 inhibitor, demonstrating meaningful clinical benefit as monotherapy and in combination across B-cell malignancies.
AI Summary
BeOne Medicines reported new clinical data on sonrotoclax, a next‑generation investigational BCL2 inhibitor, showing meaningful benefit both as a single agent and in combinations across B‑cell malignancies. The results highlighted deep, durable responses in relapsed/refractory (R/R) mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL), and rapid undetectable minimal residual disease (uMRD) in treatment‑naive CLL when paired with other drugs.
In a Phase 1/2 study of R/R MCL, sonrotoclax monotherapy achieved an overall response rate (ORR) of 52.4% and complete response (CR) rate of 15.5%. Median duration of response was 15.8 months and median time to response was 1.9 months. Side effects were manageable, most commonly neutropenia, infections, and pneumonia.
In heavily pretreated R/R CLL, sonrotoclax monotherapy showed an ORR of 76% with CR/CRi of 19% and a best blood uMRD rate of 49%, with a median time to blood uMRD4 of about 5.8 months.
Combinations were especially strong in treatment‑naive CLL: sonrotoclax plus zanubrutinib produced 100% ORR and high uMRD rates (91% at 48 weeks, 98% by 96 weeks), with rapid times to uMRD and no clinical tumor lysis observed. Triplet and other doublet combos also showed deep, fast, and durable responses and were generally well tolerated.
Read Announcement- Drug:
- sonrotoclax
- Announced Date:
- November 26, 2025
- Indication:
- Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Announcement
BeOne Medicines Ltd announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton's tyrosine kinase (BTK) inhibitor.
AI Summary
BeOne Medicines announced that the U.S. Food and Drug Administration has accepted and granted Priority Review to a New Drug Application for sonrotoclax, a next‑generation BCL2 inhibitor. The submission seeks approval to treat adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) following prior therapy with a Bruton’s tyrosine kinase (BTK) inhibitor. If approved, sonrotoclax would become the first BCL2 inhibitor for R/R MCL in the U.S., addressing a significant unmet need in this aggressive cancer.
The NDA is supported by data from the global, multicenter Phase 1/2 study BGB‑11417‑201, which enrolled 125 heavily pretreated MCL patients. Sonrotoclax met its primary endpoint of overall response rate as assessed by an independent review committee and showed encouraging results for complete response rate, duration of response, and progression‑free survival. The treatment was generally well tolerated with manageable risks.
BeOne will present the full results at ASH 2025 and is participating in FDA Project Orbis to support concurrent international review and potential access.Read Announcement
- Drug:
- sonrotoclax
- Announced Date:
- October 13, 2025
- Indication:
- Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Announcement
BeOne Medicines Ltd y announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
AI Summary
BeOne Medicines announced that the FDA has granted Breakthrough Therapy Designation to sonrotoclax, a next-generation investigational BCL2 inhibitor, for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL). This designation highlights early positive results from a Phase 1/2 study showing promising safety and effectiveness in MCL patients.
The Phase 1/2 BGB-11417-201 trial involved adult MCL patients who had prior treatment with a BTK inhibitor and an anti-CD20 therapy. Topline data showed deep and durable responses, suggesting sonrotoclax could become the first and only BCL2 inhibitor approved in the U.S. for relapsed or refractory MCL.
BeOne has also requested to join Project Orbis, an FDA initiative that allows simultaneous review of cancer therapies by multiple health agencies to speed up global patient access. The company plans to present full study results at an upcoming medical meeting, while the Phase 3 CELESTIAL-RRMCL study is already underway.
Read Announcement- Drug:
- sonrotoclax
- Announced Date:
- August 29, 2025
- Indication:
- Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Announcement
BeOne Medicines Ltd announced positive topline results from a Phase 1/2 study (BGB-11417-201) of sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, in adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton's tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy. BeOne plans to present the full data at an upcoming medical meeting.
AI Summary
BeOne Medicines Ltd announced positive topline results from its global, multicenter Phase 1/2 study (BGB-11417-201) of sonrotoclax, a next-generation investigational BCL2 inhibitor, in adults with relapsed/refractory mantle cell lymphoma (MCL) after BTK inhibitor and anti-CD20 therapy.
The trial enrolled 125 heavily pretreated patients; the dose-finding part evaluated daily sonrotoclax at 160 mg and 320 mg before selecting 320 mg for expansion. The study met its primary endpoint of overall response rate (ORR), with clinically meaningful and durable responses confirmed by an independent review committee. Secondary outcomes—including complete response rate, duration of response, and progression-free survival—were also encouraging. Sonrotoclax was generally well tolerated, with manageable side effects.
BeOne plans to present the full data at an upcoming medical meeting and will submit these results to global regulatory authorities for review and potential approval in relapsed/refractory MCL.
Read Announcement
HERIZON-GEA-01 FDA Regulatory Events
HERIZON-GEA-01 is a drug developed by BeOne Medicines for the following indication: Advanced or Metastatic Gastroesophageal Adenocarcinoma.
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:
- HERIZON-GEA-01
- Announced Date:
- April 29, 2026
- Indication:
- Advanced or Metastatic Gastroesophageal Adenocarcinoma
Announcement
BeOne Medicines Ltd announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2-positive (HER2) gastric, gastroesophageal junction, or esophageal adenocarcinoma.
AI Summary
BeOne Medicines announced that the U.S. Food and Drug Administration has granted Priority Review to a supplemental Biologics License Application (sBLA) seeking approval of TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy. The request is for first-line treatment of unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma.
The sBLA is based on the first interim analysis of the global Phase 3 HERIZON-GEA-01 trial. In that analysis, the TEVIMBRA plus ZIIHERA and chemotherapy regimen produced a statistically significant median overall survival of 26.4 months — an unprecedented result in this difficult-to-treat disease — suggesting the combination could change clinical practice for patients with advanced HER2+ gastroesophageal adenocarcinoma.
Priority Review shortens the FDA review timeline, reflecting the potential public health importance of the new treatment option. The trial compared ZIIHERA plus chemotherapy with and without TEVIMBRA against trastuzumab plus chemotherapy as first-line therapy.
Read Announcement- Drug:
- HERIZON-GEA-01
- Announced Date:
- November 17, 2025
- Indication:
- Advanced or Metastatic Gastroesophageal Adenocarcinoma
Announcement
BeOne Medicines Ltd announced positive top-line results from the Phase 3 HERIZON-GEA-01 trial evaluating ZIIHERA® (zanidatamab), a HER2-targeted bispecific antibody, in combination with chemotherapy, with or without PD-1 inhibitor TEVIMBRA® (tislelizumab), as first-line treatment for HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction, and esophagus.
AI Summary
BeOne Medicines reported positive Phase 3 HERIZON-GEA-01 results showing ZIIHERA (zanidatamab) plus chemotherapy, with or without PD‑1 inhibitor TEVIMBRA (tislelizumab), improved outcomes as first‑line treatment for HER2‑positive metastatic gastroesophageal adenocarcinoma. Both ZIIHERA arms produced clinically meaningful, highly significant progression‑free survival (PFS) gains versus trastuzumab plus chemotherapy. The ZIIHERA+TEVIMBRA+chemotherapy arm also showed a statistically significant overall survival (OS) benefit, while ZIIHERA+chemotherapy showed a meaningful OS effect with a strong trend toward significance at this first interim analysis. Benefits were seen in both PD‑L1 positive and PD‑L1 negative subgroups, and both combinations improved objective response rate (ORR) and duration of response (DOR) versus control.
The global randomized trial enrolled 914 patients across about 300 sites and compared three arms: ZIIHERA+chemotherapy+TEVIMBRA, ZIIHERA+chemotherapy, and trastuzumab+chemotherapy, with PFS and OS as dual primary endpoints. Safety for the ZIIHERA combinations was consistent with known profiles and showed no new signals. An additional OS interim analysis for ZIIHERA+chemotherapy is planned, and full data will be presented in early 2026.
Read Announcement
BGB-B2033 FDA Regulatory Events
BGB-B2033 is a drug developed by BeOne Medicines for the following indication: hepatocellular carcinoma (HCC).
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:
- BGB-B2033
- Announced Date:
- December 18, 2025
- Indication:
- hepatocellular carcinoma (HCC)
Announcement
BeOne Medicines Ltd announced that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track Designation for BGB-B2033, its GPC3x4-1BB bispecific antibody for the treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression on or after prior systemic treatment.
AI Summary
BeOne Medicines announced that the U.S. Food and Drug Administration has granted Fast Track Designation for BGB-B2033, a GPC3x4-1BB bispecific antibody for adult patients with hepatocellular carcinoma (HCC) whose disease has progressed on or after prior systemic treatment. Fast Track status can speed the development and review of drugs that address serious conditions with unmet medical needs.
BGB-B2033 targets GPC3, a tumor-specific antigen common in HCC, and 4-1BB, a T‑cell co‑stimulatory receptor. The molecule is designed with reduced antibody-dependent cellular cytotoxicity (ADCC) to help limit systemic toxicity. BeOne is conducting a global Phase 1 trial (NCT06427941) testing the drug alone and in combination with the PD‑1 inhibitor TEVIMBRA (tislelizumab) to assess safety and anti-tumor activity. The Fast Track designation reflects an encouraging profile in advanced HCC and may help accelerate further clinical development.
Read Announcement
Tislelizumab FDA Regulatory Timeline and Events
Tislelizumab is a drug developed by BeOne Medicines for the following indication: Recurrent or Metastatic Nasopharyngeal 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:
- Tislelizumab
- Announced Date:
- October 20, 2025
- Indication:
- Recurrent or Metastatic Nasopharyngeal Cancer
Announcement
BeOne Medicines Ltd. announced the presentation of data from two pivotal Phase 3 trials – RATIONALE-307 and 312 – offering new evidence of the benefits of its PD-1 inhibitor, TEVIMBRA® (tislelizumab), at the European Society of Medical Oncology 2025 Congress (ESMO 2025) in Berlin, Germany, October 17-21.
AI Summary
BeOne Medicines Ltd. presented new data at the European Society of Medical Oncology Congress 2025 in Berlin. Two pivotal Phase 3 trials, RATIONALE-307 and RATIONALE-312, showed strong clinical benefits of TEVIMBRA® (tislelizumab), a PD-1 inhibitor, in lung cancer. RATIONALE-307 revealed that TEVIMBRA plus chemotherapy significantly improved overall survival compared with chemotherapy alone in patients with squamous non-small cell lung cancer, regardless of PD-L1 levels and despite high crossover. Long-term safety was consistent with earlier findings, with most severe side effects linked to chemotherapy. RATIONALE-312 confirmed three-year efficacy and safety of first-line TEVIMBRA plus chemotherapy in extensive-stage small cell lung cancer, showing sustained survival gains in both intent-to-treat and PD-L1-positive groups.
Early results from BGB-26808, an investigational HPK1 inhibitor given alone or with TEVIMBRA, also displayed promising antitumor activity and a manageable safety profile in advanced solid tumors.
Read Announcement- Drug:
- Tislelizumab
- Announced Date:
- August 27, 2025
- Indication:
- Recurrent or Metastatic Nasopharyngeal Cancer
Announcement
BeOne Medicines Ltd. announced that the European Commission (EC) has approved TEVIMBRA (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by TEVIMBRA monotherapy as adjuvant treatment, for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
AI Summary
BeOne Medicines Ltd. announced that the European Commission approved TEVIMBRA (tislelizumab) with platinum-based chemotherapy as neoadjuvant treatment followed by TEVIMBRA alone as adjuvant therapy for adults with resectable non-small cell lung cancer at high recurrence risk.
The decision is based on the final analysis of the Phase 3 RATIONALE-315 trial. When given before and after surgery, TEVIMBRA plus chemotherapy significantly improved overall survival versus chemotherapy with placebo, and sustained benefits in event-free survival.
Survival gains were consistent across patient groups regardless of PD-L1 status, disease stage, or histology. The safety profile matched earlier findings, with no new safety signals. Common severe side effects included reduced neutrophil and white blood cell counts.
This EU approval raises TEVIMBRA’s approved solid tumor uses to nine, including five lung cancer indications. As only the second PD-1 inhibitor showing a survival benefit in this perioperative setting, it offers a new treatment option for patients facing high risk of cancer recurrence.
Read Announcement- Drug:
- Tislelizumab
- Announced Date:
- July 10, 2025
- Indication:
- Recurrent or Metastatic Nasopharyngeal Cancer
Announcement
BeOne Medicines Ltd. announced that the European Commission has approved TEVIMBRA® (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy.
AI Summary
BeOne Medicines Ltd. announced that the European Commission has approved TEVIMBRA® (tislelizumab) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC) who cannot have curative surgery or radiotherapy. This approval is based on the positive results from the RATIONALE-309 study, which showed that the combination significantly improved progression-free survival. In the study, patients receiving TEVIMBRA with chemotherapy had a 48% lower risk of disease progression or death compared to those who received a placebo with chemotherapy. The encouraging data from this study provides new hope for patients facing this rare and difficult-to-treat cancer, offering them an effective treatment option that can help delay disease progression and allow for longer survival.
Read Announcement
BRUKINSA® (zanubrutinib) FDA Regulatory Events
BRUKINSA® (zanubrutinib) is a drug developed by BeOne Medicines for the following indication: Inhibitor of Bruton's tyrosine kinase.
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:
- BRUKINSA® (zanubrutinib)
- Announced Date:
- June 25, 2025
- Indication:
- Inhibitor of Bruton's tyrosine kinase
Announcement
BeOne Medicines Ltd announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of a new film-coated tablet formulation of BRUKINSA® (zanubrutinib) for all approved indications.
AI Summary
BeOne Medicines Ltd announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion on a new film-coated tablet formulation of BRUKINSA® (zanubrutinib). The CHMP recommendation supports the tablet version for all approved indications and marks an important step toward its potential approval across Europe. This decision will now be reviewed by the European Commission, which is responsible for granting marketing authorization in the European Union as well as in European Economic Area countries such as Norway and Iceland.
The tablet formulation is designed to offer patients a more convenient treatment option. It is bioequivalent to the existing capsule version, allows for flexible once- or twice-daily dosing, and simplifies dose adjustments. This innovation aims to make it easier for patients, particularly those with B-cell cancers, to manage their treatment regimen.
Read Announcement
