Delcath Systems stumbled yesterday after the FDA sent back its application for approval of a catheter-based system for delivering chemotherapy directly to the liver. Now the company ($DCTH) wants to meet with U.S. regulators to discuss what is needed to resubmit its application for approval of the chemosaturation system.
The New York-based company has a unique system of delivering high levels of chemotherapy to specific organs while minimizing the amount of the drug that enters the blood steam. In December, the firm filed for FDA approval of the system in patients with metastatic melanoma in their liver. The system involves a catheter that is inserted into the femoral artery and advanced to the liver, where the chemotherapy drug melphalan is released. It then removes the drug from the patient's blood with a filtration system and returns it into the body to reduce toxic exposure to the rest of his or her organs.
In a late-stage clinical trial reported in April, Delcath showed that its treatment was able to provide 214 days of median progression-free survival in liver cancer patients on its treatment compared with 70 days of progression-free survival among patients who got the best alternative care treatment.
While this approach offers a potential way of reducing dose-limiting toxicity of chemotherapy, the FDA wants to know about Delcath's manufacturing plant inspections and additional safety data before the agency accepts its application for approval of the system, according to the company. The firm is now saying that it wants to resubmit its New Drug Application for the product to the FDA by Sept. 30, 2011. Meanwhile, Delcath CEO Eamonn Hobbs says that the company is on track with its application for marketing approval of the product in Europe and he expects to be addressing that market by mid-year.
Still, the FDA's refusal to file letter announced yesterday appears to have made some investors uneasy about Delcath's stock. The firm's stock price fell by 38 percent on Tuesday to close at $7.01 per share.
- here's the company's release