Accelerated Approval: Acrotech’s Confirmatory Trial For Folotyn, Beleodaq More Than A Decade Behind Schedule

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.