Health & Public Health
BRUKINSA gets FDA priority review, BeOne says
BeOne Medicines said the US Food and Drug Administration accepted and granted Priority Review to its application for BRUKINSA in combination with rituximab for adults with previously untreated mantle cell lymphoma.
The company said the supplemental New Drug Application is supported by Phase 3 MANGROVE trial data comparing BRUKINSA, also known as zanubrutinib, plus rituximab with bendamustine plus rituximab.
BeOne said the BRUKINSA combination reduced the risk of disease progression or death by 43% compared with bendamustine plus rituximab in the trial.
The company said that, if approved, the combination would be the first chemotherapy-free, BTK inhibitor-based regimen for adult patients with previously untreated mantle cell lymphoma.
Full MANGROVE results are due to be presented during a plenary scientific session at the 68th American Society of Hematology Annual Meeting on December 13, 2026.
Uncertainty notes
The treatment has not been approved for this first-line mantle cell lymphoma use in the supplied information.
The supplied information did not include an FDA decision date.
Source
AFP news report published on .