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.

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

More from US FDA Performance Tracker

More from Regulatory Trackers