The US Food and Drug Administration (FDA) has approved a breakthrough melanoma treatment. The first melanoma drug to receive FDA approval in 13 years, Yervoy (ipilimumab) is also the first therapy proven to extend overall survival for advanced stage melanoma patients. Yervoy may offer many patients a 2-year survival advantage, with a smaller percentage of patients being virtually cured.
Melanoma is the deadliest form of skin cancer. When discovered early, it can usually be cured with surgery alone, but once it spreads (metastasizes) throughout the body, treatment options are limited.
Yervoy is an immune protein that blocks the function of a molecule called CTLA-4. CTLA-4 works as a brake on the immune system; by blocking it, Yervoy enables the immune system to identify, attack and eliminate melanoma cells.
In a 2010 report published in the New England Journal of Medicine, melanoma patients previously treated unsuccessfully with other agents who received Yervoy or Yervoy plus a melanoma vaccine lived on average 32 percent longer than those who received the vaccine alone. And 24 percent were alive after two years, compared with just 14 percent of those treated with the other therapy.
Now, in new, as yet unpublished research, Yervoy was found to increase overall survival in inoperable stage III or stage IV melanoma patients who had not received prior therapy. The FDA thus has approved the drug for previously untreated patients as well, broadening its use.
“As melanoma incidence continues to rise, we are delighted that this new therapy will extend life and improve the quality of life for many patients with metastatic melanoma,” said Perry Robins, MD, President, The Skin Cancer Foundation.
Published on June 12, 2011