U.S. FDA Grants Priority Review to BeOne Medicines’ BRUKINSA Combination in First-Line Mantle Cell Lymphoma
Business Wire•04/11/2026•09:13 ET
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Key Highlights
- ➤FDA grants Priority Review to BRUKINSA plus rituximab frontline MCL application
- ➤MANGROVE regimen cut progression or death risk 43% versus bendamustine plus rituximab
- ➤BRUKINSA plus rituximab met primary progression-free survival endpoint, HR=0.57
- ➤MANGROVE enrolled 510 patients across 157 active sites worldwide
- ➤EMA accepted, and China’s CDE accepted, additional BRUKINSA MCL applications
Expert Statements
Amit Agarwal, Chief Medical Officer, Hematology, BeOne Medicines
“In newly diagnosed mantle cell lymphoma, chemoimmunotherapy remains a mainstay of frontline treatment despite the toxicity burden it carries. The FDA’s acceptance of our application brings us closer to a chemotherapy-free, BRUKINSA-based option that significantly reduces the risk of disease progression or death. BRUKINSA's ability to drive deeper, more powerful responses is what makes a chemotherapy-free approach now possible. We look forward to working closely with the FDA to make our foundational BTK inhibitor available to patients as quickly as possible.”
U.S. FDA Grants Priority Review to BeOne Medicines’ BRUKINSA Combination in First-Line Mantle Cell Lymphoma
If approved, BRUKINSA plus rituximab would be the first and only chemotherapy-free, BTK inhibitor-based regimen for adult patients with previously untreated mantle cell lymphoma
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