Delcath’s Melblez Chemosaturation System To Face ODAC Scrutiny
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s Oncologic Drugs Advisory Committee will review the drug/device combination for treatment of patients with unresectable ocular melanoma that is metastatic to the liver. The system, which uses the chemotherapy drug melphalan, has shown significant improvement in hepatic progression-free survival.
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Significant improvement in hepatic progression-free survival was inadequate to outweigh significant toxicities and a negative overall survival trend as the panel unanimously opposed approval of Delcath’s Melblez Kit May 2. But the review gave FDA a platform to discuss the tradeoffs involved in oncology drug reviews and the balance between risks and benefits.