(By Balaseshan) Delcath Systems Inc. (NASDAQ:DCTH) said it has submitted a New Drug Application (NDA) for proprietary chemosaturation system to the U.S. regulatory authorities.
The company's proprietary chemosaturation system is used 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.
In Delcath's Phase 3 clinical trial, comparing treatment with its 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 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 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.
DCTH is trading up 1.49% at $2.03 on Wednesday. The stock has been trading between $1.40 and $4.74 for the past 52 weeks.