MEI/Kyowa Kirin Show More Data Supporting Zandelisib’s Safety Profile
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.
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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.
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.
PI3K-delta inhibitors have often suffered from safety and tolerability issues, but Phase II data show higher efficacy and lower discontinuation rates for zandelisib than others in the class.