Under sponsor's current timetable, a single, two-part trial for pralatrexate and belinostat would not complete until 2030, resulting in respective delays of 21 and 16 years in confirming or refuting clinical benefit following accelerated approval. ODAC will discuss Acrotech’s delayed confirmatory trial program on 16 November.
How long is too long when it comes to confirming or refuting clinical benefit of an accelerated approval drug?
That question is at the heart of a US Food and Drug Administration advisory committee meeting on 16 November on two anti-cancer agents that have the longest ongoing postmarketing requirements