The FDA’s Oncologic Drugs Advisory Committee voted 16-0 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.
A final FDA decision is slated to be released Sept. 13.
"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 in prepared remarks. "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¢ today, 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 today.
"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.
A Delcath spokesman did not immediately respond to requests for comment.