BMY Bristol Myers Squibb Co

The U.S. Food and Drug Administration approved the first therapy combining two cutting-edge cancer drugs that unleash the body's immune system against tumors. The combination will cost more than $250,000 per patient for the first year of treatment, Bristol-Myers Squibb Co. said.

Bristol-Myers said Thursday the FDA approved the use of its drugs Yervoy and Opdivo for the treatment of advanced melanoma, a deadly form of skin cancer. Each immunotherapy previously was approved individually to treat melanoma; they work by different mechanisms to fight tumors.

A Bristol-funded study showed a combination of the two drugs significantly shrank tumors in 60% of melanoma patients, versus 11% of patients receiving Yervoy alone. The combination also increased the risk of serious adverse events such as the gastrointestinal disorder colitis.

Yervoy is given as a fixed regimen of four doses over 12 weeks. The cost for the initial 12-week phase of the combination is about $141,000, and then $12,500 a month for Opdivo alone, totaling roughly $256,000 if a patient stays on therapy for a year, according to a Bristol-Myers spokeswoman. Opdivo is taken until a patient experiences disease progression or unacceptable toxicity from the drug. Subsequent full-year costs of therapy would be about $150,000 for Opdivo alone.

Write to Peter Loftus at peter.loftus@wsj.com and Ron Winslow at ron.winslow@wsj.com

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(END) Dow Jones Newswires

October 01, 2015 11:25 ET (15:25 GMT)

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