Aug. 10 Quick Takes: FDA approves Janssen’s first-in-class bispecific for MM

Janssen’s transformation of the multiple myeloma (MM) market continues with the FDA approval of Talvey talquetamab, the first bispecific T cell engager targeting CD3 and GPRC5D to reach the market. The bispecific antibody was granted accelerated approval to treat relapsed or refractory MM in patients who have received at least four prior lines of therapy. Talvey’s approval comes with a risk evaluation and mitigation strategy (REMS) and a black box warning for cytokine release syndrome and neurologic toxicity. 

It joins BCMA-targeting CAR T cell therapy Carvykti ciltacabtagene autoleucel, which is partnered with Legend Biotech Corp. (NASDAQ:LEGN) and Tecvayli teclistamab, a bispecific CD3 x BCMA antibody, in Janssen’s list of recently approved new modalities for the indication. Both Talvey and Tecvayli are partnered with  Genmab A/S (CSE:GMAB; NASDAQ:GMAB). ...