Delcath Receives FDA Fast-Track Status for Cancer Treatment

Delcath Systems said its system for delivering high dose chemotherapy to specific organs and body regions received fast-track status from the FDA for treating metastatic melanoma in the liver with melphalan, a currently approved anticancer agent. The FDA decision was reached following the recent meeting at which the company and National Cancer Institute (NCI) researchers presented the results from the initial clinical trial which Delcath sponsored at the NCI. While the trial was not designed to prove efficacy, and the numbers were too low to make any statistical claims, the NCI study demonstrated reductions in the size of melanoma tumors in the liver of some of the patients treated with the Delcath system.

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