Adcomm Says Focused Confirmatory Trials Needed for Oncology Drugs That Lack Data

Two oncology drugs that hold the records for the longest-marketed accelerated approval cancer drugs without confirmed clinical benefit and safety profiles need shorter, more focused study in a subgroup, members of the Oncologic Drugs Advisory Committee agreed in a meeting on Thursday, expressing concerns about the sponsor’s proposal for a large phase 3 trial.

Folotyn (pralatrexate) and Beleodaq (belinostat) won accelerated approval in 2009 and 2014, respectively. Sponsor Acrotech’s plan for an extensive phase 3 trial would extend this period of unconfirmed use until it reads out in 2030, potentially exposing hundreds more people to two drugs that have never been proven to really help their disease, or even to be completely safe.

The committee proposed two alternatives that might generate the needed data quicker. The FDA could withdraw the accelerated approvals for both drugs, vastly expanding the pool of unexposed patients who could then enter a randomized study. 

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