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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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.
Company also withdraws Ukoniq, a P13K inhibitor, just 14 months after accelerated approval in two lymphoma indications. US oncology drugs panel will discuss safety concerns with the PI3K class on 21 April, but FDA has already staked out its position in a Lancet commentary that a new development approach is needed with survival as the ultimate safety endpoint.
TG Therapeutics is withdrawing the PI3K-delta inhibitor from the market and halting enrolling in other umbralisib oncology studies to focus attention on ublituximab in relapsing multiple sclerosis.