Kite’s Axi-Cel CAR-T: No Adcomm, No Problem
Next CAR-T in line at US FDA, Kite’s axicabtagene ciloleucel, looks headed toward an early approval with the agency confirming no panel will be scheduled, according to the firm. But the company and FDA may have benefited from an advisory committee review.
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At recent industry events, Novartis and Kite Pharma highlighted opportunities and addressed challenges they face as they prepare to commercialize their CAR-T therapies. A report from Datamonitor Healthcare.
Gilead's newly acquired CAR-T therapy Yescarta, developed by Kite Pharma, won FDA approval for certain B cell lymphomas on Oct. 18 and the company set its price $102,000 below Novartis's competing therapy Kymriah, which was approved in a small pediatric leukemia indication.
Gilead's Kite acquisition may finally have appeased investors' thirst for a major deal with a transaction that will diversify revenue and expand its oncology portfolio.