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

Drug Faces Longer Path To Market

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

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