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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An observational single-arm study and a dose-optimization study are planned if the FDA does not withdraw accelerated approval of the multiple myeloma drug, Oncopeptides says. If an additional confirmatory trial is needed, company suggests two different approaches, one of which is almost a repeat of the OCEAN study, the results of which remain in dispute.
Seeking to head off US FDA withdrawal of its alkylating agent, sponsor says pomalidomide comparator in OCEAN confirmatory trial rendered overall survival results difficult to interpret because immunomodulatory drugs are detrimental in elderly patients. CDER says IMiD analysis is exploratory and cannot negate adverse overall survival finding with Pepaxto.
Company’s appeal of the US FDA’s formal request to voluntarily withdraw accelerated approval of the multiple myeloma agent is expected to follow the streamlined procedures created in last year’s omnibus legislation, which would preclude a second advisory committee review of melflufen’s fate.