‘Dangling’ Cancer Indications In US: New Year Brings New Withdrawals Of Accelerated Approvals
Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.
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Oncology Center of Excellence Director Richard Pazdur also says that he will not grant an accelerated approval if the confirmatory trial is not underway, even if the product shows safety and efficacy.
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.
More than seven months after the Oncologic Drugs Advisory Committee voted that Pepaxto and Copiktra had negative benefit-risk profiles in their labeled indications, the drugs' approvals remain intact. Oncopeptides is still considering whether to heed the FDA's request to withdraw the Pepaxto NDA, even though the drug is not currently marketed. Secura Bio says Copiktra remains on the market and available for prescribing.