Yervoy

~ Dr. Jihua Cheng

On October 28, 2015, the U.S. Food and Drug Administration approved ipilimumab (Yervoy® Injection), for the additional indication of 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.

The approval was based on improvement in recurrence-free survival in a randomized (1:1), double-blind, placebo-controlled trial in 951 patients with resected Stage IIIA (lymph node >1 mm), IIIB, and IIIC (with no in-transit metastases) histologically confirmed cutaneous melanoma. The median recurrence-free survival was 26 and 17 months in the ipilimumab (n=475) and placebo (N=476) arms, respectively and was statistically significant.

The recommended dose and schedule for ipilimumab for adjuvant treatment of melanoma is 10 mg/kg administered intravenously over 90 minutes every 3 weeks for 4 doses followed by 10 mg/kg every 12 weeks for up to 3 years. In the event of toxicity, doses are omitted, not delayed.

Significant adverse reactions (10%) include fatigue (41%), headache (15%), pruritus (24% to 31%), skin rashes (19% to 29%), nausea (35%), diarrhea (32%), decreased appetite (27%), vomiting (24%), constipation (21%), abdominal pain (15%), anemia (12%), cough (16%), difficult breathing (15%) and fever (12%). Reference: Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711-723.

How this drug works: Ipilimumab is classified as a monoclonal antibody. Monoclonal antibodies are a relatively new type of “targeted” cancer therapy. Ipilimumab works by targeting the CTLA-4 antigen on normal and malignant T-cells. The mechanism of action of ipilimumab’s effect in patients with melanoma is possibly through boosting T-cell mediated anti-tumor immune responses.

CLICK HERE to learn more about Yervoy (Ipilimumab).

CLICK HERE to view the News about FDA approves Yervoy to reduce the risk of melanoma returning after surgery

CLICK HERE to learn more about Dr. Jihua Cheng, MD.