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Oncopeptides’ Pepaxto: US FDA Vexed By Adverse Survival, Failed PFS, Lack Of Dose Optimization

 
• By Sue Sutter

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.

Life ring
Oncopeptides' many post hoc, subgroup analyses cannot save Pepaxto from the adverse survival results in OCEAN, FDA says. • Source: Shutterstock

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.

In a briefing document released ahead of the 22 September ODAC meeting, Food and Drug Administration oncology reviewers said melphalan flufenamide, or melflufen, demonstrated a potential detriment in overall survival in the OCEAN confirmatory trial, which was required as a condition of accelerated

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