Counting The Cost Of Delay For Revlimid Front-line Myeloma Approval
Executive Summary
Fear of second primary cancers foils Celgene’s filing of Revlimid for front-line/maintenance myeloma in Europe. Meanwhile, debate continues about the clinical value and high cost of prolonged treatment, and new options for relapse patients emerge, notably Onyx’s Kyprolis and Celgene’s pomalidomide.
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Labeling includes new warning for development of second primary malignancies and more language about other kinds of adverse events, but there is already widespread off-label use and analysts don’t expect the warnings to have much impact.
Celgene Has A Swift Start For Pomalyst Launch
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Onyx’s Kyprolis Sails Through FDA Panel, Boosted By Confirmatory Trial Plans
The Oncologic Drugs Advisory Committee overwhelmingly concluded that carfilzomib has a positive risk/benefit assessment in relapsed/refractory myeloma. Onyx’s fully enrolled Phase III confirmatory trial, and the company’s plans for a second study that will commence soon, gave the committee confidence in recommending accelerated approval despite the limitations of a single-arm study.