Delcath Systems' ($DCTH) cancer-drug delivery device suffered a hitch as the FDA said the associated risks likely outweigh any benefit.
The Melblez device, a catheter-based system designed to deliver the chemotherapy melphalan directly to the liver, now requires further testing by the New York-based company at the behest of U.S. regulators. But the extent of the changes, based on a high treatment-related mortality rate, could dash any hopes of reaching a timely approval.
Prior to the most recent decision, the FDA narrowed the scope of what the Melblez device could do, indicating its use only for metastatic melanoma that arises in the eye. The problem is with the delivery of the melphalan, the FDA wrote in a review: The agency cited a 7% toxic death rate due to severe marrow suppression, hemorrhaging and gastrointestinal perforation due to the leaking of melphalan into the bloodstream from faulty filters.
The Street reports that Delcath is considering a new filter for the system, but it must first go through the trial process, which could take longer than it's worth. Already, by around 3 p.m. ET Tuesday, Delcath slid almost 38% on Wall Street.
Ocular melanoma is the most common primary intraocular malignant tumor in adults, according to the FDA, and a quarter to half of those patients will develop metastatic disease within two to 5 years of diagnosis. Currently, there are no FDA-approved drugs for the treatment of metastatic ocular melanoma.
- here's the FDA review (PDF)
- here's FierceMedicalDevices' take
- and here's The Street's report
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