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
BRUKINSA® and Tislelizumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BRUKINSA® (zanubrutinib) - FDA Regulatory Timeline and 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.
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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:
- 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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