FDA Will Make Advisory Committee Review Of Accelerated Approvals An Annual Event
FDA plans to hold a yearly session with its Oncology Drugs Advisory Committee on cancer drugs granted accelerated approval as a means of holding sponsors' feet to the fire with regard to conducting confirmatory trials.
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With Spectrum’s Beleodaq’s accelerated approval for peripheral T-cell lymphoma, FDA rolls Folotyn accelerated approval requirement into one post-marketing trial that will provide answers on both drugs – including which is better against standard of care.
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.
With two Phase III trials already in progress, Onyx Pharmaceuticals Inc. looks well-positioned for an FDA accelerated approval of its proteasome inhibitor carfilzomib in relapsed and refractory multiple myeloma – and if accelerated approval is not granted, it should have data to resubmit roughly a year later.