Shots:
- The US FDA has granted BTD to sonrotoclax for adults with r/r MCL & accepted BeOne’s request for participation in Project Orbis for concurrent global review of the therapy
- Decision was based on P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on sonrotoclax (160 or 320mg, QD), while Part 2 enrolled 103 pts on 320mg QD after ramp-up
- Topline results were released in Aug 2025, showing deep & durable responses in r/r MCL pts, with full data to be presented in a future meeting, plus a P-III (CELESTIAL-RRMCL) trial of sonrotoclax in r/r MCL is underway
Ref: Beone Medicine | Image: Beone Medicine | Press Release
Related News:- BeOne Medicines Reports Topline P-III (BGB-11417-201) Trial Data on Sonrotoclax in R/R Mantle Cell Lymphoma (MCL)
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