U.S. FDA Grants Priority Review to BeOne Medicines’ BRUKINSA Combination in First-Line Mantle Cell Lymphoma

What happened: The U.S. FDA accepted and granted Priority Review to the supplemental New Drug Application for BRUKINSA (zanubrutinib) plus rituximab in previously untreated mantle cell lymphoma. Why it matters: If approved, the regimen would be the first and only chemotherapy-free, BTK inhibitor-based option for this frontline setting. BeOne's Chief Medical Officer said the acceptance brings the company closer to a chemotherapy-free BRUKINSA-based option. Market: +10.2% today ($231.60), +25.5% YTD, 1.6x vol — as of 08:45 UTC

The U.S. FDA accepted and granted Priority Review to the supplemental New Drug Application for BRUKINSA (zanubrutinib) plus rituximab in previously untreated mantle cell lymphoma.

If approved, the regimen would be the first and only chemotherapy-free, BTK inhibitor-based option for this frontline setting. BeOne's Chief Medical Officer said the acceptance brings the company closer to a chemotherapy-free BRUKINSA-based option. Market: +10.2% today ($231.60), +25.5% YTD, 1.6x vol — as of 08:45 UTC