March 26, 2011

Melanoma Drug Cleared To Extend Life

A drug from Bristol-Myers Squibb Co. shown to help prolong the lives of people suffering from advanced skin cancer has been approved by the US Food and Drug Administration on Friday.

The injectable drug, called Yervoy (ipilimumab), is used for late-stage melanoma. Bristol-Myers Squibb aims to use the drug to harness the body's immune system to target and attack melanoma tumors.

"Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment," said Richard Pazdur, director of the Office of Oncology Drug Products at the FDA's Center for Drug Evaluation and Research.

"Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient's life," Pazdur told AFP in a statement.

Melanoma is the most dangerous form of skin disease. More than 68,000 new cases of melanoma were diagnosed in the United States in 2010 and nearly 8,700 people with the skin disease died, according to the National Cancer Institute.

Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen (CTLA-4). The molecule may help to slow down or turn off the body's immune system, affecting the body's ability to fight off cancerous cells. Yervoy works by allowing the body's immune system to recognize, target, and attack cells in melanoma tumors.

The FDA based its approval on results of a phase 3 randomized clinical trial involving 679 patients with late-stage cancer and who had stopped responding to other FDA-approved treatments.

Results of the trial showed that people who were treated with Yervoy lived an average of ten months, compared to 6.5 months for a control group of patients who received an experimental anti-cancer vaccine.

The World Health Organization reports that skin cancer causes 66,000 deaths annually around the world, with about 80 percent of those being melanomas.

The FDA has only approved two other drugs for melanoma. The last drug was cleared more than a dozen years ago. Neither of the two previously released drugs has been shown to greatly prolong the lives of cancer patients.

While the biotech drug only worked in a small percentage of the patients studied, experts say it is an important milestone in treating melanoma, which has been notoriously unresponsive to therapy.

"Clearly this is not a home run, but it's a solid base hit," Tim Turnham, director of the Melanoma Research Foundation, told The Associated Press. "And because we see other things in the pipeline, we think this the first in a series of important new therapies for melanoma."

Although Yervoy is seen as a potentially important therapy for melanoma patients, it also carries several side effects. The side effects are related to its effect on the immune system and include diarrhea, swelling of the colon, rash and fatigue. It can cause fatal immune system reactions in some people. The most common severe reactions are inflammations of the colon and small intestine, liver, and skin, as well as nerve damage and endocrine disease.

The FDA said about 12.9 percent of melanoma patients had severe fatal immune system reactions during the clinical trials. The agency said the drug maker will have to create a risk evaluation strategy designed to identify and reduce the risks associated with the drug.

One Yervoy therapy user, Mike Brockey of Frederick, Maryland, was diagnosed with late-stage melanoma in 2008 and tried both previous treatments of melanoma before starting therapy with the new one last September. He received recommended infusion doses through November, and although it took time for the drug to take effect, he said his latest scans show the tumors are inactive.

"This is the first time in two years I had a sense that anything was going in the right direction," said Brockey.

Researchers said about 85 percent of patients had little response to the treatment, but said response rates should improve when the drug is used earlier in the disease cycle.

"I think the direction this is headed is toward intervening earlier, when patients' immune systems are still intact, rather than waiting until they are so sick," Dr. Anna Pavlick, director of the New York University's melanoma program, told AP.

Bristol-Myers reported on Monday that Yervoy also improved survival time when used as a first-line treatment against advanced skin cancer in patients who hadn't used any other treatments. Those patients are generally less sick than those studied by the company and could potentially see longer survival times.

Bristol said it would release those findings at the annual meeting of the American Society of Clinical Oncology in June.

Bristol said it would also disclose pricing details of the drug later.

John Boris, an analyst with Citi Investment Research, estimated that Yervoy (ipilimumab) could see more than $960 million in sales by 2015.

In afternoon trading, shares of Bristol-Myers was up 2.1 percent, or 56 cents, to $26.98.


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