New Melanoma Treatment

FDA approves metastatic melanoma treatment. The New York Times (3/25, Pollack) reported, "The first drug shown to prolong the lives of people with the skin cancer melanoma won approval from the Food and Drug Administration on Friday." The Los Angeles Times (3/26, Zajac) reported that Yervoy (ipilimumab), "marketed by Bristol-Myers Squibb Co. of Princeton, NJ, is the first FDA-approved treatment for metastatic melanoma in 13 years and has triggered particular interest among oncologists because there are indications that, in addition to prolonging some patients' lives, it may cure others." Although patients with "early stages of the disease can usually be treated successfully with surgery," existing treatment options for "late-stage melanoma, including chemotherapy and Proleukin (aldesleukin) -- the last drug approved for the disease -- are effective only in a limited number of patients." According to the AP (3/26, Perrone), study results showed The biotech drug "only worked in a small segment of patients studied, and on average they lived just four months longer than patients given older medications." But experts say the drug is "an important milestone in treating melanoma, which is often unresponsive to therapy." IIpilimumab works by "blocking a molecule linked to melanoma called CTLA-4, which interferes with the protective activity of white blood cells." Medscape (3/25, Mulcahy) reported that in phase 3 randomized clinical trial, "patients receiving ipilimumab plus a peptide vaccine (glycoprotein 100) had a median survival of 10 months, compared with 6.4 months for patients receiving the vaccine alone (P < .001). Patients receiving ipilimumab alone had a nearly identical median survival -- 10.1 months -- in the 3-group clinical trial (P < .003)." HealthDay (3/25, Roberts) note that "about 13 percent of users suffered severe-to-fatal autoimmune reactions. As a result, guides will be distributed with the drug, informing doctors and patients of the medication's potential risks," the agency said.