FDA Grants Priority Review for Zanubrutinib Combination in Untreated Mantle Cell Lymphoma

The U.S. FDA has granted Priority Review to BeOne Medicines' supplemental New Drug Application for zanubrutinib (BRUKINSA) combined with rituximab. This combination targets adults with previously untreated mantle cell lymphoma, based on Phase 3 MANGROVE trial results showing a 43% reduction in disease progression or death risk. Priority Review accelerates the FDA's evaluation process.