Clinical Benefit Of Hepatic Progression-Free Survival Confronts ODAC

A REMS may not be sufficient to address serious toxicity questions about Delcath Systems’ Melblez kit for resectable ocular melanoma that is metastatic to the liver, FDA says in briefing materials for the May 2 advisory committee review of the combination product.

The future of Delcath Systems Inc.’s Melblez Kit for resectable ocular melanoma that is metastatic to the liver appears to depend on whether the Oncologic Drugs Advisory Committee believes improvement in hepatic progression-free survival is sufficient to demonstrate clinical benefit.

The Melblez Kit, which ODAC will review May 2, contains melphalan (GlaxoSmithKline PLC’s Alkeran) and the Delcath Hepatic Delivery...

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