BeOne Medicines gets FDA accelerated approval for BEQALZI (sonrotoclax) in R/R MCL

BeOne Medicines Ltd.

FDA approved BEQALZI for R/R mantle cell lymphoma after ≥2 prior therapies including a BTK inhibitor.
Phase 1/2 trial showed ORR 52%, CR 16%, median DOR 15.8 months; safety generally well tolerated.
Continued approval contingent on confirmatory CELESTIAL-RRMCL trial (NCT06742996) now underway.
BEQALZI is the first new BCL2 inhibitor approved in the U.S. in a decade and the only one for MCL.
Also approved in China for R/R MCL and CLL/SLL; EMA review ongoing; Fast Track for Waldenström.

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