Did MEI/Kyowa Kirin Beat The PI3K Tolerability Trap?
Zandelisib Shows Unexpectedly Positive Data
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.
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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.
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.
The agency has suspended enrollment in Ukoniq trials while also hinting at greater scrutiny of “the continued marketing” of the drug.