You are here

FDA Rejects Cancer Drug, Melblez (Melphalan)

Drug treats rare eye cancer that spreads to the liver (September 13)

The FDA has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for the 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.

A CRL is issued by the FDA when the review of a file is completed and questions remain that preclude approval of the NDA in its current form.

The FDA comments included a statement that the drug’s developer (Delcath Systems, Inc.) must perform another “well-controlled randomized trial to establish the safety and efficacy of [the] Melblez Kit using overall survival as the primary efficacy outcome measure,” and which “demonstrates that the clinical benefits of [the] Melblez Kit outweigh its risks.”

In a clinical trial, 7% of 122 patients died due to side effects related to treatment with the kit.

About 4 months ago, an independent panel of FDA advisors unanimously recommended against approving the therapy.

Sources: Delcath Systems, Inc.; September 13, 2013; and Reuters; September 13, 2013.

Recent Headlines

Two-Thirds of U.S. Alzheimer’s Cases Are Women, And It’s Not Just Because They Live Longer
Recarbrio Should be Reserved For Limited/No Alternative Antibacterial Treatment Cases
Breast Cancer, Gastrointestinal Tumors Most Common Types
NY Hospitals Required to Implement Protocols in Suspected Cases
Presence of BOK Protein Key for Positive Treatment Response
Patient Access to Inhaler Use Data Could Improve Asthma Management
Overall Survival 4.3 Months’ vs. 1.5 Months for Traditional Regimens