Delcath Receives CRL from FDA for Melbleztm Kit NDA
Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) received September 12, 2013 regarding the New Drug Application (NDA) for Delcath's MelblezTM 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. A CRL is issued by the FDA when the review of a file is completed and questions remain that precludes approval of the NDA in its current form. The FDA comments included a statement that Delcath must perform another "well-controlled randomized trial(s) to establish the safety and efficacy of Melblez Kit using overall survival as the primary efficacy outcome measure," and which "demonstrates that the clinical benefits of Melblez Kit outweigh its risks." In addition to the FDA requirement to conduct an additional clinical trial(s) using the product the Company intends to market, Delcath is evaluating the other requirements contained in the letter, and will review potential regulatory paths forward with the FDA. About Delcath Systems Delcath Systems, Inc. is a specialty pharmaceutical and
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