FDA approves Bristol-Myers melanoma drug

WASHINGTON Fri Mar 25, 2011 4:21pm EDT

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WASHINGTON (Reuters) - The first drug to help patients with advanced melanoma live longer won U.S. approval on Friday, a major step in the fight against one of the deadliest types of cancer.

Bristol-Myers Squibb Co shares rose 3.2 percent to close at $27.29 after the Food and Drug Administration approved its drug under the brand name Yervoy for patients in the late stages of the disease. Analysts see sales reaching $820 million in 2015, according to Thomson Reuters data.

Advanced melanoma can quickly spread from the skin to internal organs, such as the brain. Once melanoma spreads, the average survival is typically six to nine months.

"Late-stage melanoma is devastating, with very few treatment options," Dr. Richard Pazdur, the FDA's head of cancer drugs, said in a statement.

Yervoy is the first FDA-approved therapy to "clearly demonstrate that patients with metastatic melanoma live longer," he said.

About 68,000 new cases of melanoma were diagnosed in the United States in 2010 and about 8,700 people died from the disease, according to the National Cancer Institute.

Yervoy will be available within weeks, Bristol-Myers spokesman Ken Dominski said. In a company study, the intravenous medicine extended survival of advanced melanoma patients by an average of four months.

Marlene Wertheimer, an 80-year-old Palm City, Florida, resident, said she started Yervoy infusions in 2008 after the disease had spread from her scalp to her lungs, brain, liver and spine. Her tumors slowly started to shrink and then disappeared. Her hair turned white, which researchers have said may be a sign the drug is working.

"It turned my hair snow white overnight. But you know what? It's a small price to pay to go through all this to be feeling okay," she said.

A $30,000 INFUSION

The FDA cleared the medicine for advanced melanoma patients not yet treated for the disease, or for patients who tried other therapies. The drug's generic name is ipilimumab.

The FDA said it was requiring steps to inform doctors and patients about risks of the drug "due to the unusual and severe side effects," including fatal autoimmune reactions.

Yervoy is given in a 90-minute infusion every three weeks for a total of four doses. The therapy will cost $30,000 per infusion, or $120,000 for the entire course of treatment, Dominski said.

The drug is an engineered version of a human protein that targets CTLA-4, a molecule that acts like a brake on the immune system. By gumming up the brake, the drug unleashes the immune system to seek and destroy tumors.

The drug may help Bristol-Myers weather the looming patent expiration on anti-clotting drug Plavix, which it sells with Sanofi-Aventis SA. Les Funtleyder, fund manager for Miller Tabak & Co, which owns Bristol-Myers shares, said Yervoy's sales could eventually top $1 billion annually.

A company study tested the drug in patients who had tried other treatments. Patients who got Yervoy lived an average of 10 months, compared with just over six months if they got an experimental treatment called GP-100.

A second study showed the drug extended the lives of patients who had not yet tried other options. The FDA included that group in the approval.

Common side effects from Yervoy include fatigue, diarrhea, skin rash and inflammation of the intestines. Nearly 13 percent of patients suffered "severe to fatal" autoimmune reactions. Severe problems were treated by stopping the drug and providing steroids, but not all patients responded, the FDA said.

Doctors have welcomed Yervoy as a major advance, but note it does not help everyone and new options are needed.

Roche Holding Ltd, GlaxoSmithKline and privately held Plexxikon, which is being bought by Daiichi Sankyo Co Ltd, are among the companies testing other potential melanoma treatments.

Yervoy "is hopefully the beginning of many, many good things to come. God knows it's been long enough that we've waited," said Dr. Anna Pavlick, director of the melanoma program at The Cancer Institute at New York University's Langone Medical Center.

(Reporting by Lisa Richwine, Julie Steenhuysen and Bill Berkrot; editing by Michele Gershberg, Phil Berlowitz and Andre Grenon)

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