In what could be a deathblow for Delcath Systems ($DCTH), an FDA panel of experts voted unanimously that the risks of the company's drug-device combo to treat cancer outweighed any benefits.
Reuters reported on the 16-0 vote late Thursday, after the advisory panel meeting concluded. And while the FDA doesn't have to follow the panel's recommendation, it hasn't often veered from it. And that could spell trouble for the company's increasingly beleaguered cancer treatment designed to address a rare form of eye cancer after it spreads to the liver.
As Reuters notes, the treatment has two components: a chemotherapy drug melphalan hydrochloride and its Delcath Hepatic Delivery System device. And the FDA has already signaled its disapproval of the treatment combo in its current form. Just two days ago, the FDA delayed its approval decision until Sept. 13, in part because it expressed serious concern about Delcath's use of a filter in the drug/device combo that seemed to promote severe adverse reactions in patients. While Delcath has said it would switch to a new filter, the FDA wants the company to launch another randomized clinical trial to test it first.
Earlier on May 2, Nasdaq halted trading of Delcath's shares during the FDA discussion, The Wall Street Journal reports, at just under 80 cents per share. And the company has been slashing jobs to cut costs.
- here's the Reuters story
- and here's the WSJ article