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FDA approves ipilimumab, an immunotherapy, to treat metastatic melanoma
Date:3/25/2011

New York, NY, Mar. 25, 2011 The U.S. Food and Drug Administration (FDA) announced today its approval of a new treatment for advanced melanoma, the deadliest and most difficult-to-treat form of skin cancer. The drug, a monoclonal antibody called ipilimumab, is the first treatment of any kind ever shown in a large, randomized phase III clinical study (study MDX010-20) to improve overall survival in patients with metastatic melanoma who no longer respond to standard therapy. It is also the first in an emerging class of therapies called "checkpoint blockade," which enhance the immune system's ability to attack cancer by interfering with immunological checkpoints that slow or stop immune cell activation and proliferation in the presence of tumors or chronic viral infection.

"The approval of ipilimumab to treat advanced metastatic melanoma is a game changer not only for the thousands of people fighting this disease, but also for the entire field of oncology," says Jill O'Donnell-Tormey, Ph.D., executive director of the Cancer Research Institute (CRI), a nonprofit organization that since 1953 has worked to advance the science of tumor immunology. "It represents a major leap forward in our understanding of the role the immune system can play in controlling canceran understanding made possible through decades of intensive laboratory and clinical researchand demonstrates how we can now apply this knowledge to develop new and powerful immune-based therapies that extend cancer patients' lives."

New data released earlier this week from another pivotal phase III clinical trial (study CA184-024) show the antibody also extends survival in patients with metastatic melanoma who have not received prior therapy. The study compared the effects of combining ipilimumab with chemotherapy (dacarbazine) versus chemotherapy alone. Although dacarbazine has been part of the standard of care for metastatic melanoma for more than 30 years, it has never been shown to incre
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Contact: Brian Brewer
bbrewer@cancerresearch.org
212-688-7515 x242
Cancer Research Institute
Source:Eurekalert

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