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BLA Accepted: Novartis Inches Ahead In CAR-T Race With Kite

 
• By Mandy Jackson

Novartis may very well have the first CAR-T therapy approved in the US, beating its rival Kite Pharma to the finish line, since the FDA has accepted the Swiss big pharma's BLA for priority review. Kite says it will complete its rolling BLA submission in a different indication by the end of March.

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Novartis AG shot ahead of Kite Pharma Inc. in the race to get the first chimeric antigen receptor T cell (CAR-T) therapy approved in the US for hematological malignancies, announcing on March 29 that its biologic license application (BLA) for CTL019 (tisagenlecleucel-T) has been accepted by the FDA for priority review.

Kite, meanwhile, remains on track to complete its rolling BLA submission for axicabtagene ciloleucel (KTE-C19; axi-cel) by the end of the first quarter, or by March 31

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