The FDA recently approved a new cancer drug for patients with advanced stages of melanoma (skin cancer).  Melanoma has proven to be one of the most diffcult cancers to treat effectively.  In a study of patients who had advanced melanoma, those who got an experimental drug lived a median of about 10 months, compared with 6.4 months for those in a control group. After two years, about 23 percent of those who got the drug were alive, compared with 14 percent in the control group.  While 4 months might not sound significant, Dr. Steven J. O’Day of the Angeles Clinic and Research Institute in Santa Monica, Calif., a lead investigator in the melanoma trial, called the result “historic,” adding, “This is the first randomized placebo-controlled trial ever to show a survival benefit in Stage 4 melanoma.”

Ipilimumab (marketed as Yervoy®) is an anti-cytotoxic T-lymphocyte antigen (CTLA)-4 monoclonal antibody that has been approved in the US for the first- or second-line treatment of patients with malignant melanoma.  In English, that means the drug basically removes checks on the immune system, by blocking the action of T cells.  T cells are often referred to as the “soldiers” of the immune system which initiate the fight against invading cells.  It should also be noted that 10-15% of patients who took Yervoy in this study suffered severe side effects because their immune systems attacked their own organs. 7 out of 540 who received ipilimumab died from these immune effects, according to reports of the study published online by The New England Journal of Medicine.

Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in the United States during 2010, and about 8700 people died from the disease, according to the National Cancer Institute.  “Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. Ipilimumab “is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment.”

Bristol-Myers Squibb, makers of Yervoy, are hoping that the drug also proves effective in the treatment of prostate cancer.  

According to the FDA and Yervoy’s website, common adverse effects from autoimmune reactions associated with ipilimumab use include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone), and inflammation of the intestines (colitis).

Posted by: Gayle R. Lewis, Esquire