Delcath Systems ($DCTH) failed to impress the FDA with its cancer drug delivery system Melblez, as the U.S. authority asked the company in a complete response letter for further trials before the chemotherapy device can move forward.
In a May staff review from the FDA, the administration showed concern for the adverse conditions--leading to 7% patient mortality in trials--that came about as a result of filters in the device that allowed the chemotherapeutic agent melphalan to leak into the bloodstream. Although the system was designed to treat ocular melanoma that had metastasized to the liver by secluding the organ and dousing it with melphalan, the drug's escape into other parts of the body led to serious conditions such as hypotension, marrow suppression, infections, hemorrhage, gastrointestinal perforation and more. The FDA found strong indications that the drug exposure contributed to some of these problems, according to the review.
Based on the review, the administration pushed its decision to Sept. 13, at which point it dealt New York-based Delcath the news that further trials would be required to move forward with the Melblez device. And the rejection came days after the company ousted its CEO, Eamonn Hobbs, leaving two deputies to take the helm, likely in anticipation of the letter. Delcath, needless to say, is struggling--stock in the company has dropped almost 70% in 2013.
So what happens next? In April, The Street reported that Delcath was considering a new filter for the system, but that would require a brand new trial process, a step the company and its shareholders might not be willing to take. As of now, Delcath says it "will review potential regulatory paths forward with the FDA."
- here's the release
- and here's FierceMedicalDevice's take