FDA grants priority review to BeOne Medicines’ BRUKINSA combination

The U.S. Food and Drug Administration (FDA) has granted priority review to a supplemental New Drug Application from BeOne Medicines for the use of BRUKINSA (zanubrutinib) in combination with rituximab. The treatment is intended for adult patients with previously untreated mantle cell lymphoma (MCL).

The decision follows results from the Phase 3 MANGROVE clinical trial, which involved 510 patients across 157 global sites. Data indicated that the combination regimen significantly reduced the risk of disease progression or death by 43% compared to the standard chemoimmunotherapy of bendamustine plus rituximab.

If approved, this would provide a chemotherapy-free, Bruton tyrosine kinase (BTK) inhibitor-based regimen for frontline MCL treatment. Full results from the MANGROVE study are expected to be presented at the 68th American Society of Hematology Annual Meeting in December 2026.