Delcath Systems has submitted its proprietary chemosaturation delivery system's new drug application (NDA) to the US Food and Drug Administration (FDA).
The application includes the use of chemosaturation system along with melphalan hydrochloride to treat patients with unresectable metastatic melanoma in the liver.
The chemosaturation system was compared with best alternative care (BAC) in the company's Phase 3 clinical trial.
According to independent review committee (IRC) blinded intent-to-treat (ITT) analysis, the data showed that patients treated with chemosaturation therapy experienced a statistically significant extension in median hepatic progression free survival of 5.4 months (p=0.0001, hazard ratio 0.39) longer than patients treated with BAC.
In addition, the company included its Generation 2 filter in its NDA submission as a technical change to the Chemistry, Manufacturing, and Control (CMC) module.
Delcath Systems president and CEO Eamonn Hobbs said the company believes that its 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 U.S. patients that we accelerate the potential availability of Generation 2," Hobbs added.
"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 1, 2 and 3 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."
