~ 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

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