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Delcath’s Melblez Chemosaturation System To Face ODAC Scrutiny

 
• By Sue Sutter

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.

FDA’s Oncologic Drugs Advisory Committee on May 2 will consider approval of Delcath Systems Inc.’s chemosaturation system Melblez Kit for a narrower indication than originally requested by the company, in part due to advances in the treatment of melanoma.

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More from North America

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• By Michael McCaughan

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