Delcath Systems Inc.’s (NSDQ:DCTH) ChemoSat organ-targeting chemotherapy system will get a pre-new drug application meeting with the FDA mid-January 2012, the company announced this week.
The ChemoSat device uses a system of tubes to localize the delivery of toxic chemotherapy agents by isolating the targeted organ — in this case, the liver — from the rest of the body’s bloodstream.
"With the filing of our NDA by the end of the year, we would anticipate a six-month review and U.S. approval in mid-year 2012 for the indication of melanoma mets to the liver," CEO Eamonn Hobbs told MassDevice during an interview in June.
The FDA refused Delcath’s original NDA earlier this year over concerns that the information provided was insufficient for review, an the company "embarked on a monitoring program to go back to the patient records and mine hospitalization data that the FDA is specifically looking for," Hobbs told us.
The watchdog agency’s response came as a surprise, Hobbs told us, as clinical trials had been designed and conducted under a special FDA agreement.
"We conducted our Phase III trial under an SPA, a special protocol assessment, which is a formal agreement with the agency on all the facts and circumstances associated with the trial," Hobbs said. "They wanted additional hospital data that was not collected in the original case report forms that were approved as part of the SPA."
Delcath won CE Mark approval in the European Union in April, where the device is considered a Class III medical device.
"We got a very broad indication in our CE Mark that covers all liver cancers. That translates into about 95 percent of the world market opportunity outside the U.S," Hobbs said. "Since the market opportunities are so much bigger outside the U.S., if I had to choose between the two regulatory approvals, I would take the one we got, the CE Mark, far ahead of the FDA’s, from a commercial perspective."
Delcath shares were up 5 percent to $3.74 in mid-afternoon trading today. The New York-based company plans to unveil its third quarter earnings report in a conference call on Monday, Nov. 7.