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FDA clears first melanoma drug to extend life

MATTHEW PERRONE | 3/29/2011, 7:05 p.m.

Average survival was 10 months with ipilimumab versus just more than six months for the others. But a very small group of patients survived longer than six years, suggesting that with more study the drug could be targeted to those who will respond the most.

About 85 percent of patients had little response to the drug. Researchers say the response rate should improve as 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,” said Dr. Anna Pavlick, director of the New York University’s melanoma program. Pavlick, a spokeswoman for the Skin Cancer Foundation, helped conduct several early-stage trials of ipilimumab.

Bristol-Myers reported last week that ipilimumab also improved survival times when used as a first-line treatment against advanced skin cancer in patients who hadn’t taken any other treatments. These patients are generally less sick than those first studied by the company and could see even 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 disclose pricing details of the drug later.

Citi Investment Research analyst John Boris estimates ipilimumab could reach total sales of $960 million by 2015.

Ipilimumab is one of several key medications Bristol is counting on to sustain its business in coming years. Like most drugmakers, the New York-based company faces a wave of patent expirations that will expose key drugs to generic competition. The company will lose patent protection for both its blood thinner Plavix, the world’s second-best-selling drug, and for the high blood pressure drug Avapro in the first half of 2012.

AP Health Writer Marley Seaman contributed to this story from New York.