ARTICLE | Company News
Priority Review for Kite's CAR T therapy
May 26, 2017 6:44 PM UTC
Kite Pharma Inc. (NASDAQ:KITE) said FDA accepted and granted Priority Review to a BLA for chimeric antigen receptor (CAR) T cell therapy axicabtagene ciloleucel (KTE-C19) to treat refractory aggressive non-Hodgkin’s lymphoma (NHL). The PDUFA date is Nov. 29.
Kite based the submission on the Phase II ZUMA-1 study in the indication. The company reported an objective response rate of 44% and complete response rate of 39% at a median follow-up of 8.7 months for patients treated with the therapy...