FDA requires new trial for Melblez Kit for Liver Cancer
Delcath Systems, Inc.announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for 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.
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."
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