New melanoma drug gets green light from FDA

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Bristol-Myers Squibb’s new melanoma drug Yervoy won approval from the FDA on Friday after a randomized clinical trial showed that patients with metastatic melanoma treated with the drug lived about four months longer than patients in the control group — although the median survival among the treated patients was only ten months. Consisting of four infusions spread out over a three-month period, this complete course of Yervoy treatment will cost $120,000.

Considered a novel cancer drug, Yervoy is an immunotherapy that uses a monoclonal antibody to unleash the body’s immune system. One of its problems is that the drug’s effects can often take weeks to manifest. Also, about one out of eight patients may face severe or fatal autoimmune reactions, including colitis, diarrhea, hepatitis, endocrine dysfunction and skin problems.

Killing about 8,700 people annually, there were another 68,000 new cases of melanoma in the U.S. last year, a number that continues to rise, according to the American Cancer Society.

ACSH staffers were delighted to be joined this morning by former ACSH trustee Dr. Jack C. Fisher, Emeritus professor of surgery and former head of the Division of Plastic Surgery at the University of California in San Diego. Drawing upon his own clinical experience, he reminds us that about 5 percent of melanoma cases are already deeply penetrating into surrounding tissues upon first diagnosis, resulting in a high fatality rate despite treatment. Another 5 percent are lentigo melanoma, which while large in size, develop very slowly and are easily removed. “The remaining cases are everything in between, which means that they’re superficial and sit there for a long time before spreading. Unfortunately, most melanoma lesions are ignored for many years.”

When asked by Dr. Fisher whether he was surprised by the FDA’s approval of Yervoy, an expensive drug with only a small benefit in median survival, ACSH's Dr. Gilbert Ross replies, “There are two reasons it was approved. First, lead study author Dr. Gerald P. Linette, assistant professor of medicine at Washington University in St. Louis was quoted as stating that Yervoy is ‘a drug that extended survival in a meaningful way,’ and second, it is an immunomodulator, not a chemotherapy.”

“It’s a first-in-class therapy, and the FDA usually likes those,” adds ACSH’s Dr. Josh Bloom. “Or perhaps they are beginning to loosen their oppressive policies from the last decade.”