Shots:
- The US FDA has granted accelerated approval to BeOne‘s Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU
- Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52% ORR (16% CR), mTTR of 1.9mos., & mDoR of 15.8mos. at median response follow-up of 11.9mos.
- Continued approval remains contingent on confirmation of clinical benefit in the ongoing P-III (CELESTIAL-RRMCL) trial, while Beqalzi is also being evaluated in combination regimens, incl. with Brukinsa for CLL, with updated data expected at ASCO’26
Ref: Businesswire | Image: BeOne | Press Release
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