FDA panel backs Schering-Plough cancer drug

October 5, 2009 BY MATTHEW PERRONE , AP Business Writer

(AP) -- Federal health advisers voted 6-4 on Monday that the potential benefits of a Schering-Plough drug outweigh its toxic risks as a treatment for late-stage skin cancer.

The often follows the panel's advice, though it is not required to.

Schering-Plough has asked the FDA to approve its drug PegIntron for patients whose has spread to their lymph nodes, requiring surgery. The drug is already approved as a treatment for .

Company studies of the drug showed it lengthened the period of time before cancer recurred by about nine months, though patients ultimately didn't live longer than those who did not receive the drug.

PegIntron was associated with high levels of toxicity, and 44 percent of patients dropped out of the study due to toxic side effects, which included fatigue, nausea and skin reactions.

Still, a majority of panelists said the drug's ability to slow the disease outweighed its negative side effects.

"I'm leaning in the direction that this may be helpful given that there are very few options for these patients," said panel chair Dr. Gary Lyman, of Duke University Medical Center.

The four panelists who voted against the drug said they could not endorse a product that did not appear to extend patients' lives.

"I voted no because I think survival has to be the primary endpoint here," said Dr. William Kelly, of Yale University.

Sales of Pegintron totaled $914 million in 2008. Kenilworth, N.J.-based Schering-Plough also markets Intron A, the only other FDA-approved drug for treatment of recurring skin cancer after surgery.

The panel vote was "an encouraging development toward the future treatment of melanoma," the company said in a statement.

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Explore further: FDA approves skin cancer drug

Related Stories

FDA approves skin cancer drug

October 13, 2006

The U.S. Food and Drug Administration approved a new drug to treat a rare, slow-growing skin cancer.

FDA OKs Ixempra for advanced breast cancer

October 22, 2007

The U.S. Food and Drug Administration has approved Ixempra, a new anti-cancer treatment, for use in patients with metastatic or advanced breast cancer.

FDA to review Vytorin results

January 26, 2008

The U.S. Food and Drug Administration said it is conducting a review of the cholesterol drug Vytorin based on preliminary results from a recent study.

FDA questions safety of Glaxo kidney cancer drug

October 1, 2009

(AP) -- Federal regulators said Thursday an experimental kidney cancer drug from GlaxoSmithKline may cause liver problems, potentially outweighing its ability to slow the disease.

Recommended for you

How the finch changes its tune

August 3, 2015

Like top musicians, songbirds train from a young age to weed out errors and trim variability from their songs, ultimately becoming consistent and reliable performers. But as with human musicians, even the best are not machines. ...

Machine Translates Thoughts into Speech in Real Time

December 21, 2009

(PhysOrg.com) -- By implanting an electrode into the brain of a person with locked-in syndrome, scientists have demonstrated how to wirelessly transmit neural signals to a speech synthesizer. The "thought-to-speech" process ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.