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.
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MEI shareholders declined to approve the all-stock merger that would have combined the companies’ cancer pipelines.
Merger plans follow MEI’s recent decision to shelve its own PI3K inhibitor due to class safety concerns. Combined firm will have three clinical oncology candidates, runway into 2025.
Presentations at EHA show the drug has a favorable safety profile compared with other PI3K-delta inhibitors alone and in combination with Rituxan, plus strong efficacy.