Yervoy, the first drug shown to prolong the lives of late-stage melanoma patients, has been approved by the FDA. It can be used for the treatment of late-stage metastatic melanoma, the most deadly form of skin cancer, but it does not cure the disease.
“This is really the first time in the melanoma field that there is a drug that extended survival in a meaningful way,” said Dr. Gerald P. Linette, an assistant professor of medicine at Washington University, who participated in a clinical trial of the drug.
Currently there are only two other drugs that are used to treat advanced melanoma, dacarbazine and interleukin-2. Neither has been shown to significantly extend patients’ lives, and interleukin-2 is so toxic it’s rarely used.
In a clinical trial of 676 late-stage melanoma patients for whom all other treatments had failed and for whom surgery was not an option, patients who took Yervoy lived an average of 10 months after starting treatment, while those taking an experimental vaccine lived an average of 6.5 months.
More than 20 percent of those taking Yervoy lived at least two years, while some survived even longer.
“Clearly this is not a home run, but it’s a solid base hit,” Tim Turnham, director of the Melanoma Research Foundation, told the Associated Press. “And because we see other things in the pipeline, we think this is the first in a series of important new therapies for melanoma.”
Yervoy works by using the body’s immune system to attack a tumor, and there is the potential for severe side effects — it can provoke powerful autoimmune reactions, where the immune system attacks normal cells in the body. Nearly 13 percent of patients had severe or fatal autoimmune reactions in clinical trials. Common side effects included fatigue, diarrhea, skin rash, hormone deficiencies and intestinal inflammation.
For more information on Yervoy’s approval, visit the FDA’s website.
