FDA touts new authority as ODAC hosts adcomm to review delayed confirmatory trials for accelerated approvals
The FDA’s Oncologic Drugs Advisory Committee will meet Thursday to look at two cancer drugs that first won accelerated approval in 2009 and 2014 but have failed to complete their confirmatory trials.
The two drugs are both indicated for relapsed or refractory peripheral T cell lymphoma (PTCL) and from Acrotech Biopharma: Folotyn (pralatrexate) and Beleodaq (belinostat).
The agency noted in briefing documents released Tuesday ahead of the meeting that there have been “substantial delays” in an updated confirmatory trial the sponsor proposed, as well as,
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