Zydelig Takes Major Hit, But Not A Big Blow For Gilead
This article was originally published in The Pink Sheet Daily
FDA joins European regulators in warning about fatalities in trials of Gilead’s PI3 kinase inhibitor Zydelig (idelalisib), news that is a blow for a drug that had yet to get off the ground.
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Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.
Bayer's PI3 kinase inhibitor copanlisib now has accelerated approval in a common type of non-Hodgkin lymphoma, but the drug's competitive profile still awaits Phase III data.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.