Posted on March 30th, 2011 by
The US Food and Drug Administration (FDA) has approved Yervoy™ (ipilimumab) for the treatment of melanoma that has spread to other sites or cannot be surgically removed.
Melanoma is the most deadly type of skin cancer. Each year in the United States, there are roughly 68,000 new diagnoses of melanoma and 8,700 deaths from the disease. Finding effective treatments for advanced melanoma has been challenging, and research in this area continues.
Yervoy targets a molecule known as CTLA4. CTLA4 is found on the surface of T cells and is thought to inhibit immune responses. By targeting this molecule, Yervoy may enhance the immune system’s response against tumor cells.
A Phase III clinical trial that contributed to the approval of Yervoy involved 676 people with melanoma. All had melanoma that had stopped responding to other treatments and had spread or could not be surgically removed. Study participants were assigned to one of three treatment groups: 1) Yervoy plus an experimental anti-cancer vaccine (gp100); 2) Yervoy alone; or 3) the vaccine alone.
Overall survival was 10 months among patients treated with Yervoy (with or without the gp100 vaccine), compared with six months among patients treated with the gp100 vaccine alone. Survival at two years was 24% among patients treated with Yervoy alone and 14% among patients treated with the gp100 vaccine alone.
Severe autoimmune reactions occurred in 13% of patients treated with Yervoy. Patients who experience these reactions are advised to discontinue Yervoy and begin corticosteroid therapy. The company that will market Yervoy is collaborating with the FDA on a plan to inform healthcare providers and patients about the potential risks. This process is referred to as a Risk Evaluation and Mitigation Strategy (REMS).
Yervoy is the first new treatment approved for metastatic melanoma in more than a decade.
Reference: US Food and Drug Administration. FDA news release. FDA approved new treatment for a type of late-stage skin cancer. March 25, 2011.
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