The US Food and Drug Administration accepted a supplemental application and granted Priority Review to zanubrutinib (Brukinsa) plus rituximab to treat adults with previously untreated mantle cell lymphoma. If approved, the combination will be the first chemotherapy-free, BTK inhibitor-based regimen for frontline treatment, according to BeOne Medicines, the developer of the drug.
The application is supported by data from the Phase 3 MANGROVE trial. The trial met its primary endpoint of progression-free survival, showing that the combination reduced the risk of disease progression or death compared to standard chemoimmunotherapy. The safety profile matched the known profiles of both zanubrutinib and rituximab, with no new safety signals reported according to a press release by BeOne Medicines.
The full MANGROVE results will be presented during the plenary scientific session at the 68th American Society of Hematology Annual Meeting on December 13, 2026.
Leave feedback about this