FDA OKs ipilimumab for melanoma

March 30, 2011

The Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for treatment of metastatic melanoma.

Washington - The Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for treatment of metastatic melanoma.

Yervoy is an injectable monoclonal antibody that blocks cytotoxic T-lymphocyte antigen (CTLA-4), which may play a role in inhibiting the immune system’s ability to fight off cancerous cells.

The drug’s safety and efficacy were established in a single international study of 676 melanoma patients, all of whom had stopped responding to other FDA-approved or commonly used treatments for melanoma. The subject patients’ melanomas either had spread or were inoperable.

The study was designed to measure the length of time from when treatment started until death occurred. The randomly assigned patients received Yervoy and an experimental tumor vaccine called gp100, Yervoy alone or the vaccine alone. Results show that 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 and colitis. Severe to fatal autoimmune reactions were seen in 12.9 percent of patients treated with Yervoy. When severe side effects occurred, Yervoy was stopped and corticosteroid treatment started. Not all patients responded to this treatment. Patients who did respond in some cases did not see any improvement for several weeks.

Due to the unusual and severe side effects associated with Yervoy, the therapy is being approved with a Risk Evaluation and Mitigation Strategy to alert medical professionals. Patients will be provided with a medication guide to inform them about potential side effects.