Delcath Systems has announced the Therapeutic Goods Administration (TGA) division of the Australian government has approved the Generation Two Hepatic Chemosat Delivery system for melphalan hydrochloride for listing on the Australian Register of Therapeutic Goods (ARTG). The TGA’s approval allows Delcath to market and sell the system used to treat unresectable metastatic melanoma in the liver in Australia.
“Australian regulatory approval of our Generation Two Chemosat system with melphalan for injection represents our first approval of the new system in the Pacific Rim,” said Eamonn P Hobbs, president and CEO of Delcath. “This approval is another significant milestone for Delcath, since it enhances our opportunity to address a potential market of $50-70 million as we seek an exclusive distributor in this region.”
Delcath obtained the CE mark approval for the Generation Two Chemosat Delivery system for melphalan hydrochloride in April 2012. The company has not yet received FDA approval for commercial sale of its system in the United States. The company is seeking approval for its proprietary chemosaturation system with melphalan hydrochloride as a treatment for patients with unresectable metastatic melanoma in the liver. According to the company, the new drug application for the product has been accepted for filing and substantive review by the FDA.