Bristol-Myers Drug Wins U.S. Approval to Treat Advanced Melanoma

Bristol-Myers Squibb Co. won U.S. approval to sell its drug Opdivo for advanced melanoma, part of a line of new treatments that use patients’ immune systems against cancer.

The immunotherapy was approved for patients whose skin cancer can’t be removed surgically or who haven’t responded to other drugs, according to a statement today from the Food and Drug Administration.

The drug is expected to generate $1.5 billion in sales in 2016, according to the average of seven analysts’ estimates compiled by Bloomberg.

Opdivo blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells, the FDA said. The agency in September approved another PD-1 inhibitor, Merck & Co.’s Keytruda for melanoma.

Opdivo, known chemically as nivolumab, will cost $12,500 a month, Bristol-Myers spokeswoman Carrie Fernandez said by e-mail. Keytruda has the same price.

About 76,100 people in the U.S. will be diagnosed with melanoma this year and 9,710 will die from the disease, according to the American Cancer Society.

“The continued development and approval of novel therapies based on our increasing understanding of tumor immunology and molecular pathways are changing the treatment paradigm for serious and life-threatening diseases,” Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said in the statement. Opdivo was the seventh melanoma drug approved by the FDA since 2011, he said.

Opdivo was approved more than three months ahead of schedule on the condition that Bristol-Myers, which is based in New York, conduct tests to prove that the drug will extend patients’ lives. The drug is intended for patients who tried an older Bristol-Myers drug, Yervoy, and have a gene mutation called BRAF V600.

Merck’s Keytruda also is for patients who have tried Yervoy. Keytruda was approved subject to more tests by Merck, which is based in Kenilworth, New Jersey.

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