Yervoy, a monoclonal antibody that blocks CTLA-4 (cytotoxic T-lymphocyte antigen), is used to treat patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of over 1 mm who have undergone complete resection including total lymphadenectomy.
It was first approved in 2011 to treat late-stage melanoma that cannot be removed by surgery. The latest approval extends its use to patients who are at high risk of developing recurrence of melanoma after surgery.
The safety and effectiveness of the drug as adjuvant therapy is based on results from EORTC 18071, a randomized, double blind Phase 3 trial that was carried out in 951 high-risk patients who received Yervoy or a placebo as adjuvant therapy after complete surgical removal of melanoma.
Under the study, the amount of time was measured after treatment it took for the cancer to come back and overall survival.
A total of 49% of participants taking Yervoy had a recurrence after an average of 26 months compared with 62% percent of those receiving a placebo. The analysis of overall survival data has not yet occurred.
Bristol-Myers Squibb senior vice president and head of oncology development Michael Giordano said: "The approval of Yervoy for the treatment of adjuvant melanoma underscores our scientific leadership in Immuno-Oncology, with a commitment to further developing our I-O agents – Yervoy and Opdivo – across multiple tumor types and at many stages of disease."
Resectable, Stage III melanoma represents 5%, or about 3,100 cases, of all new melanoma cases diagnosed annually. There is a 60% risk of recurrence following surgery.