The New York-based medical device company’s stock lost nearly half its value last spring after an FDA advisory panel recommended against approval for the Melblez device.
Friday, Delcath revealed in a regulatory filing that the federal watchdog agency issued a complete response letter confirming its denial of Delcath’s new drug application for the Meblez technology, which is designed to deliver the anti-cancer drug melphalan using its hepatic delivery system.
"A CRL is issued by the FDA when the review of a file is completed and questions remain that precludes approval of the NDA in its current form. The FDA comments included a statement that Delcath must perform another ‘well-controlled randomized trial(s) to establish the safety and efficacy of Melblez Kit using overall survival as the primary efficacy outcome measure,’ and which ‘demonstrates that the clinical benefits of Melblez Kit outweigh its risks,’" according to the filing. "In addition to the FDA requirement to conduct an additional clinical trial(s) using the product the company intends to market, Delcath is evaluating the other requirements contained in the letter, and will review potential regulatory paths forward with the FDA."
The FDA’s Oncologic Drugs Advisory Committee voted 16-0 in May that the risks associated with Delcath’s Melblez Kit are higher than its potential benefits for patients with unresectable ocular melanoma metastatic to the liver. Although the federal watchdog agency is not bound by its advisory panels’ recommendations, it often follows their advice.
"As we conveyed during the presentation to the ODAC, we believe our clinical trial data support Melblez Kit as an effective treatment option offering clinical benefits to patients with unresectable metastatic ocular melanoma in the liver," Delcath president & CEO Eamonn Hobbs said at the time. "While we were disappointed in today’s outcome, we will continue to work closely with the FDA throughout its ongoing evaluation of Melblez Kit. We remain committed to providing access to this promising new treatment for patients who have few choices with regard to treatments."
News of the panel’s vote sent DCTH shares down 43.5% to 44.7¢ May 3, a few days after a preliminary FDA briefing cited the deaths of 8 out of 122 patients due to complications from the Melblez treatment slashed about 40% from the stock’s April 29 close of $1.39 apiece. Wedbush Securities analyst Gregory Wade cut his rating on the stock from "outperform" to "neutral" and lowered the price target to $1.30 from $5 per share in a note to investors.
"The negative ODAC recommendation in the U.S. likely means that additional clinical studies with overall survival as an endpoint may be necessary for U.S. approval," Wade wrote.
The panel vote prompted Delcath to cut 20% of its workforce in July, its 3rd round of layoffs this year.
DCTH shares fell 8.1% to 34¢ apiece Friday and were trading at 33¢ as of about 10:45 a.m. today, down another 2.5%.