FDA OKs Gilead CAR T for rare type of lymphoma

Under Priority Review status, the FDA approves Gilead Sciences (GILD -2.5%) unit Kite Pharma’s CAR T cell therapy Tecartus (brexucabtagene autoleucel) for the treatment of mantle cell lymphoma, a rare and aggressive type of non-Hodgkin lymphoma.

The product’s labeling has a Boxed Warning regarding the risks of cytokine release syndrome (CRS) and neurotoxicities. The Risk Evaluation and Mitigation Strategy (REMS) has been combined with the REMS for Yescarta (axicabtagene ciloleucel).

https://seekingalpha.com/news/3594908-fda-oks-gilead-car-t-for-rare-type-of-lymphoma