FDA Approves Novel Immunotherapy for Advanced Melanoma

The FDA approved on Friday a new immunotherapy, ipilimumab (brand name, Yervoy), to treat metastatic melanoma.

Approval for the intravenous drug — which allows the body to fight tumors by blocking a T-lymphocyte antigen that may slow down the immune system — was based on a study of 676 patients with late-stage melanoma who randomly received one of three treatments: ipilimumab, an experimental tumor vaccine, or ipilimumab plus the vaccine. Those who received ipilimumab (either alone or with the vaccine) had better overall survival than those who only got the vaccine (median survival, 10 vs. 6.5 months).

Autoimmune reactions are common with the therapy and include colitis, diarrhea, endocrine dysfunction, fatigue, and skin rash. In addition, more severe or fatal reactions occurred in 13% of patients studied.