FDA expands approval of Bristol-Myers Squibb's Yervoy in melanoma

The FDA announced the expanded approval of Bristol-Myers Squibb's Yervoy (ipilimumab) to include use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. The immune checkpoint inhibitor was originally cleared in 2011 to treat late-stage melanoma that cannot be removed by surgery.

Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, commented "this new use of the drug in earlier stages of the disease builds on our understanding of the immune system's interaction with cancer." Yervoy, which is administered intravenously, is a monoclonal antibody that blocks CTLA-4.

The agency noted that the expanded approval was based on results of a study that included 951 patients who received Yervoy or placebo as adjuvant therapy following complete surgical removal of melanoma. Findings showed that 49 percent of participants taking Yervoy had their cancer return after an average of 26 months, compared to 62 percent of those receiving placebo, whose cancer returned after an average of 17 months.

"The science of immuno-oncology is rapidly advancing, and we are proud to be the first to demonstrate the potential of an immune checkpoint inhibitor in the adjuvant setting, an earlier stage of the disease, where patients urgently need new medicines," remarked Michael Giordano, head of oncology development at Bristol-Myers Squibb. The company noted that resectable stage III melanoma represents 5 percent, or approximately 3100 cases, of all new melanoma cases diagnosed annually in the US.

Earlier this week, Bristol-Myers Squibb reported third-quarter financial results, with revenue from Yervoy declining 31 percent to $240 million, which the company noted was partly because of increased use of its immunotherapy Opdivo (nivolumab) for melanoma.

To read more Top Story articles, click here.