Novartis, Kite Neck-And-Neck In CAR-T Race; Deaths Keep Juno In Third Place
Novartis and Kite both are set to submit their CD19-targeting CAR-T therapies for US FDA approval in early 2017, while neurotoxic deaths for two of Juno’s product candidates cast doubts on its programs.
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Novartis got a leg up on its competition Aug. 30 with an earlier-than-expected approval for Kymriah in pediatric ALL, ending the CAR-T pricing mystery with its $475,000 price tag, which the company is positioning as a relative bargain.
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.
Now that Kite Pharma Inc.’s first chimeric antigen receptor T cell (CAR-T) therapy axicabtagene ciloleucel (KTE-C19) is being submitted for US FDA approval, Chairman, President and CEO Arie Belldegrun said it is the right time to think about ways to make the company’s technology available in additional markets, like Japan and China where Kite entered into partnership agreements with Daiichi Sankyo Co. Ltd. and Shanghai Fosun Pharmaceutical Group Co. Ltd., respectively.