Delcath Systems : FDA Approves HEPZATO KIT To Treat Metastatic Uveal Melanoma In Adults

(RTTNews) - The U.S. Food and Drug Administration approved HEPZATO KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation, Delcath Systems Inc. (DCTH) said in a statement on Monday.

Metastatic uveal melanoma is a rare and aggressive form of metastatic cancer.

The company plans to have commercial product available in the fourth quarter, and patients will continue to be enrolled and treated at Expanded Access Program (EAP) sites.

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