Bristol-Myers Squibb announced that FDA has approved Yervoy (ipilimumab) 10 mg/kg, a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response.

Indication: Yervoy is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection including total lymphadenectomy.

Common Adverse Reactions: The most common adverse reactions (≥5%) in patients who received Yervoy at 10 mg/kg were rash (50%), diarrhea (49%), fatigue (46%), pruritus (45%), headache (33%), weight loss (32%), nausea (25%), pyrexia (18%), colitis (16%), decreased appetite (14%), vomiting (13%), and insomnia (10%).

Citation: Bristol-Myers Squibb receives approval from the U.S. Food and Drug Administration for Yervoy (ipilimumab) as adjuvant treatment for fully resected stage III melanoma. [news release]. Princeton, NJ: Bristol-Myers Squibb; October 28, 2015. http://news.bms.com/press-release/financial-news/bristol-myers-squibb-receives-approval-us-food-and-drug-administration-. Accessed October 28, 2015.