Schering-Plough's liver drug Pegintron squeaked past an FDA advisory committee yesterday, narrowly winning a recommendation for a new indication for patients with advanced melanoma.
The panel voted 6-4 in favor of the Schering drug's risk-benefit balance. But committee members raised concerns about the side effects of the drug, which is now approved to treat liver disease and hepatitis C as part of a two-drug cocktail. The drug has the same active ingredient as high-dose interferon, but offers a more convenient once-weekly dosing schedule, the company told the panel. Interferon is administered five times a week.
FDA staff questioned whether Pegintron's benefits would outweigh the risk of side effects. The agency noted that Pegintron increased the amount of time patients lived without the return of their cancer, but didn't improve the overall survival time. And it also comes with "substantial toxicity," the agency said, spurring side effects including blood disorders, fatigue and depression.
- check out the release from Schering
- read the Wall Street Journal story