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Onyx Files Carfilzomib For Accelerated Approval With Two Phase III Trials Ongoing

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA has expressed preference for having multiple confirmatory trials in the works to support an accelerated approval application.

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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.

FDA Accepts Onyx’s Carfilzomib Application But Denies Priority Review

“Our plan is to continue our dialogue with the FDA and see if we can address their concerns and get the accelerated approval done,” Onyx R&D chief Love told analysts. The company completed its application to treat patients with refractory and relapsed multiple myeloma in September based on results of a single-arm study, a design the agency may not be inclined to accept.

FDA Accepts Onyx’s Carfilzomib Application But Denies Priority Review

“Our plan is to continue our dialogue with the FDA and see if we can address their concerns and get the accelerated approval done,” Onyx R&D chief Love told analysts. The company completed its application to treat patients with refractory and relapsed multiple myeloma in September based on results of a single-arm study, a design the agency may not be inclined to accept.

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