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, 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 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:
- 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
Tislelizumab FDA Regulatory 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:
- 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.
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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
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