FDA approves new treatment for a type of skin cancer of late stage

The U.S. food and Drug Administration has now Yervoy (Ipilimumab) for the treatment of patients with late stage (metastatic) melanoma, the most dangerous type of skin cancer.

Melanoma is the most common cause of death from skin disease. It is estimated that 68,130 new cases of melanoma have been diagnosed in the year 2010 in the United States, approximately 8,700 people died of the disease, according to the National Cancer Institute.

"Late-stage is melanoma devastating, with very few treatment options for patients, of which none previously extended a patients life," said Richard Pazdur, m.d., Director of the Office of oncology drug of in the FDA Center for drug evaluation and research. "Yervoy is the first therapy by the FDA to indicate that patients with metastatic melanoma longer life by he admitted this treatment."

Yervoy is a monoclonal antibody, which blocked a molecule called cytotoxic T lymphocyte Antigen or CTLA-4. CTLA-4 can a slowing down or turning off the body's immune, role in impact on its ability to fight cancer cells. Yervoy works by the body's immune system to identify, target, and melanoma cells attack tumors. The drug is administered intravenously.

Safety and efficacy of Yervoy were founded in 676 patients with melanoma, in an international study. All patients in the study had ceased to respond to other FDA approved or commonly used treatments for melanoma. In addition the participants had disease, spread or, could not surgically removed.

The study is overall survival, the length of time from when this treatment until the death of the patient started to measure. Randomly assigned patients received Yervoy plus an experimental tumor vaccine of called six shot-Yervoy alone, or the vaccine alone.

Those who received the combination of the Yervoy plus vaccine or Yervoy alone there were on average about 10 months, while those who average 6.5 months lived only the experimental vaccine.

Common side effects that can use connected from the auto-immune reactions with Yervoy include fatigue, diarrhea, rash, endocrine defects (gland or hormone) and inflammation of the bowel (colitis). Autoimmune reactions were strictly serious 12.9 percent of the patients with Yervoy treated. On the serious side effects occur, Yervoy was stopped and corticosteroid treatment was started. Not all patients responded to this treatment. Patients who responded in some cases see no improvement for several weeks.

With a risk assessment and risk mitigation strategy, health care professionals about the serious risks to inform is due to the unusual and severe side effects Yervoy associated with the treatment is allowed. Medication instructions also patients, to teach them about the therapy possible side effects.

Yervoy is marketed by New York City-based Bristol-Myers Squibb.

Source:
U.S. food and drug administration