Relapsed or Refractory Mantle Cell Lymphoma (MCL)
ONCBeOne MedicinesCatalyst overview
Research summary
This catalyst tracks a Approved update for Sonrotoclax / BGB-11417 in Relapsed or Refractory Mantle Cell Lymphoma (MCL). The expected timing is based on the latest available company guidance and may change.
BGB-11417-201 trial. 8/29/25- Topline data reported. 10/13/25- Granted Breakthrough Therapy designation. 11/26/25– FDA grants priority review. Full clinical results to be presented at ASH'25 on December 7, 2025. 02/26/26:- Approved in China for R/R MCL; FDA priority review and EU MAA. FDA decision expected H1 2026. 05/06/26:- R/R MCL monotherapy NDA decision reiterated for H1 2026; ESMO adds sonrotoclax as third-line option. 05/13/26:- FDA accelerated approval granted for BEQALZI in R/R MCL after prior BTK inhibitor. 08/05/26:- BEQALZI FDA accelerated approval in R/R MCL was reiterated.
Verification
Confirm timing and program details against the company announcement or filing.