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Despite FDA Setback, MEI’s Zandelisib Could Still Break PI3K Curse

Drug Faces Longer Path To Market

 
• By Alaric DeArment

MEI/Kyowa Kirin will no longer seek accelerated approval based on a single-arm study as the FDA is calling for Phase III data due to growing conservatism regarding the PI3K class.

MEI and Kyowa Kirin face a delay due to the FDA's more conservative stance on PI3K inhibitors • Source: Alamy

MEI Pharma, Inc.’s PI3K inhibitor zandelisib faces a longer road to the market than the company anticipated as the US Food and Drug Administration has adopted a more cautious stance on the long-troubled class and discouraged the company from filing for accelerated approval based on Phase II data. But given the zandelisib’s favorable toxicity profile relative to its peers, that longer road does not mean it is doomed, though it will have to meet a high efficacy bar to be competitive.

MEI and partner Kyowa Kirin Co., Ltd. said on 24 March that they would not seek accelerated approval for...

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