Feb. 5 Quick Takes: FDA approves BMS’s liso-cel; plus AZ’s Imfinzi fails in head and neck cancer trial and updates on Reistone, Spero, Innovent and more

Bristol Myers Squibb Co. (NYSE:BMY) said FDA approved Breyanzi lisocabtagene maraleucel (informally, liso-cel), a CD19-directed CAR T cell therapy to treat adults with relapsed or refractory large B cell lymphoma, including diffuse large B cell lymphoma (DLBCL). It’s the fourth CD19 CAR T to market in the U.S. and the first approval of a therapy that originated at Juno Therapeutics Inc. Had the approval come by YE20, it would have been the second of three milestones needed to satisfy requirements of a $6.8 billion CVR issued in BMS’s $74 billion Celgene takeout. Liso-cel is under review by EMA.

Imfinzi misses in SCCHN Phase III
Anti-PD-L1 mAb Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) failed to improve overall survival vs. standard of care in the Phase III KESTREL trial as a first-line treatment for squamous cell cancer of the head and neck (SCCHN), missing the study’s primary endpoint. KESTREL tested Imfinzi with and without anti-CTLA-4 mAb tremelimumab vs. chemotherapy plus cetuximab...