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Status Quo: US Approvals For Pepaxto, Copiktra Remain Intact Despite Negative Panel Reviews

 
• By Sue Sutter

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.

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Pepaxto and Copiktra were knocked down at a September ODAC meeting, but they're still not completely out. • Source: Shutterstock

More than seven months after the US Food and Drug Administration's Oncologic Drugs Advisory Committee voted that two approved hematologic cancer drugs - Oncopeptides AB multiple myeloma treatment Pepaxto (melphalan flufenamide) and Secura Bio, Inc.'s lymphoma drug Copiktra (duvelisib) - had unfavorable benefit-risk profiles, the drugs' approvals remain in place, although only one currently is being marketed.

Oncopeptides is still weighing the FDA’s December request to voluntarily withdraw the alkylating agent Pepaxto, which remains under accelerated approval...

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