DCTH---changes NDA indication as directed by FDA. I see this as an indication approval next year is more likely.
NEW YORK, NY - December 5, 2012 -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that after recent discussions with the U.S. Food & Drug Administration (FDA), management has elected to modify the label indication it is seeking in its New Drug Application (NDA) for its proprietary chemosaturation system with melphalan hydrochloride for injection.
Although the Company's Phase 3 trial demonstrated a very positive signal in patients with liver dominant cutaneous melanoma, based upon a recommendation from the FDA, Delcath has decided to focus the Company's NDA indication on the treatment of patients with unresectable metastatic ocular melanoma in the liver. This decision is primarily due to the fact that 90% of the patients enrolled in the Company's Phase 3 trial had ocular melanoma metastases to the liver and the statistically significant efficacy data generated in the trial for this disease. Additionally, FDA-approved treatment options have evolved significantly for metastatic cutaneous melanoma over the past several years, while treatment options for unresectable metastatic ocular melanoma continue to be lacking. Given these facts, the Company believes that its data in ocular melanoma metastases in the liver, coupled with the large unmet need for treatments for this disease, presents the most compelling case for the Company's NDA. The Company hopes that a timely approval of its Chemosaturation system will represent an important step to bring benefits to those cancer patients afflicted with the disease.
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