FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma

BeOne Medicines has received U.S. Food and Drug Administration acceptance and Priority Review for its supplemental New Drug Application seeking approval of BRUKINSA combined with rituximab in adults with previously untreated mantle cell lymphoma.

The application is supported by results from the Phase III MANGROVE study, which compared the chemotherapy-free combination with bendamustine plus rituximab.

BRUKINSA, also known as zanubrutinib, combined with rituximab reduced the risk of disease progression or death by 43% compared with bendamustine plus rituximab.

The progression-free survival hazard ratio was 0.57, with a 95% confidence interval of 0.43 to 0.76 and a p value below 0.0001.

Progression-free survival was assessed by an independent review committee and represented the primary endpoint of the study.

The safety profile of BRUKINSA plus rituximab was consistent with the known safety profiles of the individual medicines, with no new safety signals identified.

Amit Agarwal, MD, PhD, Chief Medical Officer for Hematology at BeOne Medicines, said chemoimmunotherapy remains commonly used in newly diagnosed mantle cell lymphoma despite its associated treatment burden.

He said the Phase III findings support the potential for a chemotherapy-free BRUKINSA-based treatment option in this setting.

If approved, the combination would provide a chemotherapy-free BTK inhibitor-based regimen for adults receiving first-line treatment for mantle cell lymphoma.

Full results from the MANGROVE trial are scheduled for presentation during the Plenary Scientific Session at the 68th American Society of Hematology Annual Meeting on December 13, 2026.

MANGROVE, also known as BGB-3111-306, is a global randomised Phase III trial evaluating BRUKINSA plus rituximab against bendamustine plus rituximab in adults with previously untreated mantle cell lymphoma.

BeOne has also submitted applications for BRUKINSA in mantle cell lymphoma to other regulatory authorities.

A supplemental application has been submitted to the European Medicines Agency and another has been accepted by the Center for Drug Evaluation of China’s National Medical Products Administration.

BRUKINSA is already approved in the U.S. for adults with relapsed or refractory mantle cell lymphoma.

It also has U.S. approvals in chronic lymphocytic leukaemia and small lymphocytic lymphoma, Waldenström’s macroglobulinaemia, relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma.

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