Oncology company BeOne Medicines Ltd (Nasdaq: ONC) (HKEX: 06160) (SSE: 688235) reported on Wednesday that it has received US Food and Drug Administration (FDA) Priority Review for its application to use BRUKINSA (zanubrutinib) with rituximab to treat adults with previously untreated mantle cell lymphoma. If approved, the combination would be the first and only chemotherapy-free, BTK inhibitor-based regimen for this patient group.

The application is supported by the Phase 3 MANGROVE trial, in which the combination reduced the risk of disease progression or death by 43% compared with standard treatment using bendamustine plus rituximab. The study met its primary endpoint of progression-free survival, with no new safety signals identified.

Full MANGROVE results will be presented at the Plenary Scientific Session of the 68th American Society of Hematology Annual Meeting on 13 December 2026. BeOne has also submitted an application to the European Medicines Agency, while China's National Medical Products Administration has accepted the filing for review.

BRUKINSA is currently approved in the US for adults with relapsed or refractory mantle cell lymphoma and several other B-cell malignancies.