The drug significantly delayed recurrence of the cancer in patients treated post surgery.
Bristol-Myer Squibb’s CTLA-4 inhibitor ipilimumab (Yervoy) has been approved by the FDA as adjuvant treatment to prevent relapse in stage III melanoma patients post surgery.
The most aggressive form of skin cancer, stage III patients present with lymph node metastases and surgery is the most common treatment. “This new use of the drug in earlier stages of the disease builds on our understanding of the immune system’s interaction with cancer,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.
Ipilimumab was the first drug of the new breed of immunooncology agents to be approved for oncology care back in 2011, it was originally indicated for use in melanoma that has metastasized or is unresectable. A recombinant, human monoclonal antibody that binds to the CTLA-4 receptor, blockade of CTLA-4 augments T-cell activation and proliferation.
Data submitted for the current approval included a study in 951 patients administered ipilimumab or a placebo as adjuvant therapy after surgical removal of their melanoma. The primary outcome measures of the trial were recurrence-free survival and overall survival. While 49% of patients on ipilimumab saw a recurrence by an average of 26 months post-treatment, 62% of those on placebo had their cancer return within 17 months. The trial has yet to analyze overall survival data.
The drug label, according to the FDA, includes a boxed warning for the potential for fatal immune-related adverse reactions. The study reported rash, diarrhea, fatigue, itching, headache, weight loss and nausea as commonly encountered side effects. Additionally, ipilimumab can cause autoimmune disease in the digestive system, liver, skin, nervous system, as well as in the hormone-producing glands. It is contraindicated in pregnant women.