FDA Panel Narrowly Backs Schering's Pegintron For Melanoma
06 October 2009 - 3:16AM
Dow Jones News
A Food and Drug Administration panel Monday narrowly backed the
use of Schering Plough Corp.'s (SGP) Pegintron in patients with
advanced melanoma amid concerns about drug side-effects.
The panel of outside medical experts voted 6 to 4 in favor of a
question that asked if there was a favorable risk-benefit
assessment for Pegintron for the treatment of patients with Stage
III melanoma, or cancer that's spread to lymph nodes.
Pegintron is an injection already approved to treat liver
disease and Hepatitis C in combination with another drug. It
contains the same active ingredient as high-dose interferon, which
is currently approved to treat patients with advanced melanoma
following surgery to remove affected lymph nodes.
Schering said Pegintron would offer a more convenient
once-weekly dosing option compared to high dose interferon which is
given intravenously five-times a week during the initial four weeks
of treatment. The product is designed to boost the body's immune
system in order to fight disease.
During the panel meeting, the FDA questioned whether Pegintron
drug provided enough benefit to warrant approval. The agency said
Pegintron improved relapse free survival, or the time before the
cancer returned, it didn't improve overall survival. The agency
also said the drug carried "substantial toxicity" that included
blood disorders, fatigue and depression in some patients.
Susan Arbuck, a vice president at Schering-Plough's research
institute said, "we stand behind the fact that this is a better
tolerated drug and the safety profile we think is very
acceptable."
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com