Fierce Pharma November 15, 2023
An upcoming meeting of the FDA’s oncologic drugs advisory committee is slated to serve as a reminder for cancer drug developers that the agency is keeping a close eye on accelerated approvals.
External experts invited by the FDA will discuss during a meeting Thursday two accelerated approvals by Acrotech Biopharma. The two nods are for Folotyn and Beleodaq in relapsed or refractory peripheral T-cell lymphoma (PTCL), granted in 2009 and 2014, respectively.
Both indications have long passed their original timeline agreed with the FDA for providing confirmatory trial data to verify the drugs’ clinical benefit. And the final report of data from a new confirmatory trial proposed by Acrotech isn’t expected until 2030.
The FDA’s oncology staffers are now asking...
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