FDA approves new treatment for skin cancer
The FDA has approved Bristol-Myers Squibb’s Yervoy (ipilimumab) to treat patients with metastatic melanoma.
Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in the U.S. during 2010 and about 8,700 people died from the disease, according to the National Cancer Institute.
Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 may play a role in slowing down or turning off the body’s immune system, affecting its ability to fight off cancerous cells. Yervoy may work by allowing the body’s immune system to recognize, target and attack cells in melanoma tumors. The drug is administered intravenously, said the FDA.
Yervoy’s safety and effectiveness were established in a single international study of 676 patients with melanoma. All patients in the study had stopped responding to other FDA-approved or commonly used treatments for melanoma, according to the agency. In addition, participants had disease that had spread or that could not be surgically removed.
The study was designed to measure overall survival, the length of time from when this treatment started until a patient's death. The randomly assigned patients received Yervoy plus an experimental tumor vaccine called gp100, Yervoy alone or the vaccine alone, according to the FDA. Those who received the combination of Yervoy plus the vaccine or Yervoy alone lived an average of about 10 months, while those who received only the experimental vaccine lived an average of 6.5 months.
Common side effects that can result from autoimmune reactions associated with Yervoy use include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone) and inflammation of the intestines (colitis). Severe to fatal autoimmune reactions were seen in 12.9 percent of patients treated with Yervoy. Due to the unusual and severe side effects associated with Yervoy, the therapy is being approved with a risk evaluation and mitigation strategy to inform healthcare professionals about these serious risks, added the FDA.
Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in the U.S. during 2010 and about 8,700 people died from the disease, according to the National Cancer Institute.
Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 may play a role in slowing down or turning off the body’s immune system, affecting its ability to fight off cancerous cells. Yervoy may work by allowing the body’s immune system to recognize, target and attack cells in melanoma tumors. The drug is administered intravenously, said the FDA.
Yervoy’s safety and effectiveness were established in a single international study of 676 patients with melanoma. All patients in the study had stopped responding to other FDA-approved or commonly used treatments for melanoma, according to the agency. In addition, participants had disease that had spread or that could not be surgically removed.
The study was designed to measure overall survival, the length of time from when this treatment started until a patient's death. The randomly assigned patients received Yervoy plus an experimental tumor vaccine called gp100, Yervoy alone or the vaccine alone, according to the FDA. Those who received the combination of Yervoy plus the vaccine or Yervoy alone lived an average of about 10 months, while those who received only the experimental vaccine lived an average of 6.5 months.
Common side effects that can result from autoimmune reactions associated with Yervoy use include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone) and inflammation of the intestines (colitis). Severe to fatal autoimmune reactions were seen in 12.9 percent of patients treated with Yervoy. Due to the unusual and severe side effects associated with Yervoy, the therapy is being approved with a risk evaluation and mitigation strategy to inform healthcare professionals about these serious risks, added the FDA.