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…
Shots:
The P-I/II (BGB-11417-201) trial of 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
Trial met its 1EP of improved ORR per IRC & showed significant improvements across 2EPs,…

