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.
You may also be interested in...
Spectrum Puts Its Eggs In One Basket: Folotyn, Beleodaq To Share Confirmatory Trial
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.
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.
Onyx Files Carfilzomib For Accelerated Approval With Two Phase III Trials Ongoing
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.