EMA’s CHMP recommends conditional approval of Carvykti 

EMA’s CHMP has recommended approval of Carvykti and Evusheld, and label extensions for five approved therapies, including Jakavi, Kymriah and two new indications for Keytruda. 

CAR T cell therapy Carvykti ciltacabtagene autoleucel from Legend Biotech Corp. (NASDAQ:LEGN) and Johnson & Johnson (NYSE:JNJ) received a positive opinion for conditional marketing authorization to treat multiple myeloma. Carvykti led to response rates nearing 100% in heavily pretreated myeloma patients, and two-year results from the Phase I/II CARTITUDE-1 study suggest the responses are durable, and possibly curative, for many patients. The BCMA directed CAR T therapy gained FDA approval last month. ...