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BioCentury
ARTICLE | Company News

Kite's CAR T to skip advisory committee

Elizabeth S. Eaton
August 9, 2017 12:54 AM UTC

On a conference call to discuss its 2Q17 earnings, Kite Pharma Inc. (NASDAQ:KITE) said FDA has informed the company that it will not schedule an advisory committee meeting to discuss a BLA for axicabtagene ciloleucel (KTE-C19). The chimeric antigen receptor (CAR) T cell therapy is under FDA Priority Review to treat refractory aggressive non-Hodgkin’s lymphoma (NHL). Its PDUFA date is Nov. 29 (see BioCentury Extra, May 26).

Axicabtagene ciloleucel comprises autologous T cells genetically modified to express a CAR targeting CD19...

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