Delcath Confirms FDA Panel Voted 16-0 Against Benefits of Melblez Kit

Delcath Systems, Inc. DCTH today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 with no abstentions that benefits of treatment with Delcath's Melblez^TM 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. The FDA is not bound by the recommendation of its advisory committee, but will consider the committee's guidance as it evaluates the Melblez Kit New Drug Application (NDA). The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA's review and decision regarding approval of the Melblez Kit NDA is September 13, 2013. "As we conveyed during the presentation to the ODAC, we believe our clinical trial data support Melblez Kit as an effective treatment option offering clinical benefits to patients with unresectable metastatic ocular melanoma in the liver" said Eamonn P. Hobbs, President and CEO of Delcath Systems. "While we were disappointed in today's outcome, we will continue to work closely with the FDA throughout its ongoing evaluation of Melblez Kit. We remain committed to providing access to this promising new treatment for patients who have few choices with regard to treatments."