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 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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“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.