Delcath Systems, Inc., a specialty pharmaceutical and medical device company focused on oncology, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the its proprietary chemosaturation system for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The company included its Generation 2 filter in its NDA submission as a technical change to the Chemistry, Manufacturing, and Control (CMC) module.
"Our team has achieved a significant milestone with the filing of our NDA," said Eamonn P Hobbs, president and CEO of Delcath Systems. "We believe that our chemosaturation system provides the opportunity to satisfy a high unmet medical need to treat patients with unresectable metastatic melanoma in the liver. We also believe including our Generation 2 filter in the CMC module represents the fastest regulatory review path for the Generation 2 system, and that it is in the best interest of US patients that we accelerate the potential availability of Generation 2."
"We have requested priority review of our NDA by the FDA. Assuming the NDA is accepted and that priority review is granted, our expected Prescription Drug User Fee Act (PDUFA) date would be in February of next year. Based upon the strength of our phase I, II and III data, along with the limited treatment options available for patients with unresectable melanoma metastases in the liver, we believe that our application meets the FDA's criteria for priority review."
In Delcath's phase III clinical trial (April 2010 data cutoff), comparing treatment with the Company's proprietary chemosaturation system to best alternative care (BAC) revealed that patients treated with chemosaturation therapy experienced a statistically significant extension in median hepatic progression free survival (hPFS) of 5.4 months (p=0.0001, hazard ratio 0.39) longer than patients treated with BAC according to independent review committee (IRC) blinded intent-to-treat (ITT) analysis. Previously reported investigator ITT analysis of these data showed an extension in median hPFS of 6.4 months (p<0.0001, hazard ratio 0.28) longer than patients treated with BAC. Priority review is granted by the FDA to those products that address significant unmet medical needs or have the potential to provide significant improvement compared to marketed products. The FDA has previously granted Delcath two orphan drug designations for melphalan in ocular and cutaneous melanoma, which will provide the Company with exclusivity in these indications for seven years if the NDA is accepted, reviewed and approved.