FDA Advisory Committee rejects Melblez Kit (Delcath) for Ocular melanioma metastatic to the Liver
Delcath Systems, Inc. announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 with no abstentions that benefits of treatment with Delcath's Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System) for the treatment of patients with unresectable Ocular melanoma metastatic to the Liver do not outweigh the risks associated with the procedure.
Outside of the United States, the proprietary product to deliver and filter melphalan hydrochloride is marketed under the trade name Delcath Hepatic ChemosatDelivery System (Chemosat Delivery System for Melphalan.) The Company obtained authorization to affix a CE Mark for the Generation Two Chemosat Delivery System for Melphalan in April 2012.
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