FDA Approves Major Breakthrough in the Treatment of Skin Cancer

Online, March 26, 2011 (Newswire.com) - Today marks a major advance in the fight against skin cancer, as the U.S. Food and Drug Administration (FDA) approved a new immune-based therapy for the treatment of melanoma, the leading cause of death from skin cancer. In clinical studies reviewed by the FDA this cancer immunotherapy, ipilimumab, significantly improved the survival of patients with late-stage melanoma.

The incidence of melanoma has risen steadily over the past three decades, with one out of every 50 Americans at risk of developing melanoma during their lifetime. Through the use of conventional treatments, patients with advanced melanoma have a median lifespan of 6-9 months; however, the approval of this novel immunotherapy treatment gives physicians a powerful new tool to treat this challenging disease.

"This is a landmark advance for several reasons," said Society for Immunotherapy of Cancer (SITC) President, Thomas Gajewski, MD, PhD, University of Chicago. "First, this is a completely new way to treat cancer, by blocking a negative regulator of the immune response. Second, it is the first drug ever to show improved survival of metastatic melanoma patients. And third, we learned that clinical responses to immune therapies such as this one can take time, requiring some patience. FDA approval of this drug further strengthens the case for cancer immunotherapy. We anticipate other novel immune therapies that will benefit patients with cancer over the coming years."

Ipilimumab (Bristol-Myers Squibb Company) targets a key physiologic factor that serves to inhibit the body's natural immune response against tumor cells. By blocking this negative regulator, this new strategy effectively takes the foot off the brake of the immune system, allowing immune cells to attack tumors more effectively. This strategy is a major breakthrough in cancer immunotherapy, and further establishes immunotherapy as an effective cancer treatment approach to be considered along with the conventional cancer treatments of surgery, chemotherapy and radiation for patients with cancer.

Early this week, ipilimumab was reported to improve overall survival in previously untreated patients with metastatic melanoma in combination with chemotherapy compared to chemotherapy alone. Earlier results were published in the June 2010 issue of the New England Journal of Medicine by SITC board member F. Stephen Hodi, MD, Dana Farber Harvard Cancer Center in Boston, and colleagues. The study included 676 patients with inoperable, late-stage melanoma tumors that had already spread throughout the body. The researchers found that in patients who received ipilimumab treatment alone or in combination with an investigational cancer vaccine, 44% - 46% were alive one year after treatment, and 24% - 22% were alive two years after treatment. By comparison, with vaccine treatment alone, only 25% of patients were alive after one year, and just 14% were alive after two years. More encouragingly, a subset of patients have had apparent disappearance of their disease that has persisted for more than two years. Ipilimumab is being approved along with a plan to inform health care professionals and patients about important side effects that can occur with this treatment.

Through educational events and initiatives that foster scientific exchange and collaboration among basic scientists and clinical investigators from around the world, SITC is proud to advance the science and translation of immunotherapy strategies like CTLA-4 blockade that will improve the lives of patients with cancer.

Founded in 1984, the Society for Immunotherapy of Cancer (formerly the International Society for Biological Therapy of Cancer; iSBTc) is a non-profit organization of clinicians, researchers, students, post-doctoral fellows, and allied health professionals dedicated to improving cancer patient outcomes by advancing the development and application of cancer immunotherapy through interaction, innovation and leadership. For more information about SITC, please visit the Society website at www.sitcancer.org.

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