Clinical Benefit Of Hepatic Progression-Free Survival Confronts ODAC
This article was originally published in The Pink Sheet Daily
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.
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Accrual difficulties force changes that nullify Special Protocol Assessment; ongoing, randomized FOCUS trial in patients with ocular melanoma that has metastasized to liver will become single-arm study and target enrollment will be reduced by 66%.
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.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.