May 2 A panel of advisers to the U.S. health
regulator unanimously recommended against approving Delcath
Systems Inc's cancer therapy for a rare form of eye
cancer that spreads to the liver, saying it was too risky.
Concerns that the treatment may not win U.S. Food & Drug
Administration (FDA) approval have driven New York-based
Delcath's shares down by three-quarters from a year high of
$2.94 in May.
The shares fell heavily on Tuesday when FDA staff documents
were released that showed serious concerns about the risks of
the therapy, the only product Delcath has in development. ()
Trading in the shares was halted around 1300 ET when the
panel meeting convened.
There is currently no approved therapy for patients
suffering from this type of cancer but the FDA staff said there
was no indication the treatment improved overall survival or
delayed disease progression.
One of the advisers, Aman Buzdar, vice president of clinical
research at Texas-based MD Anderson Cancer Center said during
the panel discussion Thursday that though the condition has no
cure, by any yardstick the quality of life would be worse after
The panel of independent experts voted 16-0 against
recommending the therapy.
"While we were disappointed in today's outcome, we will
continue to work closely with the FDA throughout its ongoing
evaluation of Melblez Kit," Delcath Chief Executive Eamonn Hobbs
said in a statement.
The drug-device combination product consists of a
chemotherapy drug, melphalan hydrochloride, and a device known
as the Delcath Hepatic Delivery System. The two are combined in
a single package known as the Melblez Kit.
The therapy targets ocular melanoma, a rare form of eye
cancer which has spread and given rise to a malignant liver
tumor and cannot be removed surgically.
In the FDA staff briefing released on Tuesday, reviewers
noted that "substantial and severe toxicity" was identified in
the clinical trials.
Seven percent of the 122 patients treated by the drug-device
combination died as a result of treatment related side effects,
the FDA staff said.
Delcath outlined a specific risk management strategy to
reduce the risks including the presence of a 7-member
multi-disciplinary procedural team during the procedure.
However, reviewers said the risk management strategy
designed by the company could not be expected to eliminate
The FDA staff said that despite careful selection of
patients and rigorous training of those who performed the
procedure "there was a high treatment related mortality rate
that in the best-case scenario would be replicated in the
The American Cancer Society said about 2,800 adults a year
in the United States develop ocular melanoma.
Delcath said up to 70 percent of ocular melanoma patients
will develop liver cancer within 2 to 5 years of the onset of
The last trade prior to the stock's halt showed shares up
4.7 percent at $0.79 on the Nasdaq.