FDA “Regulatory Flexibility” On Accelerated Approval Must Result In Some Withdrawals
If all drugs cleared for accelerated approval succeed in their confirmatory studies, then FDA is being overly conservative in its use of the expedited approval pathway, FDA Office of Hematology and Oncology Products Director Richard Pazdur says at the AACR annual meeting.
You may also be interested in...
The presentation of the ANNOUNCE results, the failed confirmatory trial for Lilly’s Lartruvo, at ASCO re-opened questions about the accelerated approval and the appropriate way to study soft tissue sarcoma.
Lilly withdraws soft tissue sarcoma drug for failure to confirm clinical benefit two and a half years after US FDA awarded accelerated approval, becoming the fastest withdrawal yet under the regulatory pathway.
FDA retains the right to pull a breakthrough designation if subsequent data do not back up the promise seen in early clinical results, but a few failures are not expected to unduly hurt the expedited regulatory program.