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Onyx’s Kyprolis Sails Through FDA Panel, Boosted By Confirmatory Trial Plans

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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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.

Onyx’s Myeloma Drug Kyprolis Fits ODAC’s View On Accelerated Approval

FDA’s Oncologic Drugs Advisory Committee overwhelmingly endorsed the second-generation proteasome inhibitor for accelerated approval in the relapsed/refractory population. Onyx’s reliance on a single-arm study was appropriate given the lack of treatment options in a heavily pre-treated population, said ODAC members, who also looked favorably upon the company’s advanced plans for confirmatory trials.

Safety Concerns Weigh On Onyx’s Carfilzomib In Multiple Myeloma

In briefing documents released ahead of the Oncologic Drugs Advisory Committee’s June 20 review, FDA cites concerns about severe toxicities with the proteasome inhibitor and the limitations of a single-arm trial. With an overall response rate of “only” 22%, carfilzomib may not provide an advantage over available therapies in the relapsed/refractory setting, review documents state.

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