Oncopeptides AB’s bid for continued approval of the multiple myeloma drug Pepaxto (melphalan flufenamide) in the US appears to be on life support heading into an FDA Oncologic Drugs Advisory Committee meeting, notwithstanding the drug’s recent approval in Europe.
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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