Oncopeptides’ Pepaxto: US FDA Vexed By Adverse Survival, Failed PFS, Lack Of Dose Optimization
ODAC will weigh current benefit-risk profile for melphalan flufenamide, which holds accelerated approval in relapsed/refractory multiple myeloma. FDA rejects Oncopeptides’ use of numerous post hoc subgroup analyses to overcome negative survival trend in OCEAN confirmatory trial.
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Status Quo: US Approvals For Pepaxto, Copiktra Remain Intact Despite Negative Panel Reviews
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.
Oncopeptides’ Melflufen: Same Data, Different Conclusions From EMA, US FDA
The two regulators were an OCEAN apart on their interpretation of the overall survival and progression-fee survival data from the Phase III confirmatory trial. European regulators saw fit to recommend Pepaxti’s approval, even after the drug was voluntarily discontinued in the US market due to FDA concerns.
Oncopeptides Weighing Pepaxto Withdrawal Request
Drama continues for the multiple myeloma treatment as US FDA formally moves to pull accelerated approval. Oncopeptides anticipates making a decision on the request in the first quarter of 2023.