Delcath today announced that its 2nd-generation ChemoSat won regulatory approval from Australia’s Therapeutic Goods Administration and that the FDA granted the company a June 13, 2013, date for standard review of its recently accepted New Drug Application.
The New York-based company has had a string of recent wins, having in recent weeks landed expanded CE Mark approval in the European Union for ChemoSat, shortly after successfully filing its 2nd NDA with the FDA.
Delcath’s ChemoSat uses a system of tubes to localize the delivery of toxic chemotherapy agents by isolating the targeted organ from the rest of the body’s bloodstream.
The Australian approval grants the company approval to sell the 2nd-generation of the device in that country.
"Australian regulatory approval of our Generation Two ChemoSat system with melphalan for injection represents our 1st approval of the new system in the Pacific Rim," Delcath president & CEO Eamonn Hobbs said in prepared remarks. "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 must seek U.S. approval for the system under the pharmaceutical review pathway because of the melphalan hydrochloride the ChemoSat system uses to destroy cancerous tissue.
The recent luck is a welcome turnaround, as Delcath has had a rough go with the ChemoSat system in the last couple years, with inconclusive trial results and a 5-million-share stock offering that didn’t win much favor from The Street.
The troubles began when the FDA refused the company’s 1st new drug application over concerns that the information provided was insufficient for review. ChemoSat is regulated as a medical device in Europe, where it won CE Mark approval in April 2011, but as far as the FDA is concerned it is regulated as drug-device combination that also requires new drug labeling.