BMY Bristol Myers Squibb Co

By Peter Loftus and Ron Winslow 

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--a combination that will cost more than $250,000 per patient for the first full year, according to its manufacturer.

Bristol-Myers Squibb Co. 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.

The hefty price tag underscores a dilemma amid progress in cancer care: oncologists believe combinations of newer therapies have potential to improve treatment versus single-drug therapies, but the costs could strain health-care budgets as the cocktails are deployed against multiple cancer types. Bristol-Myers also is studying its Yervoy-Opdivo combination in lung cancer, which has a bigger patient population than melanoma.

"What we don't want to see is that cost becomes a factor in people getting the best kind of care that's available," said Tim Turnham, executive director of the nonprofit Melanoma Research Foundation.

He said it is difficult to assess whether the cost of the Bristol-Myers combination is justifiable because the magnitude of the treatment's benefit on patient survival isn't yet known. So far, studies have shown that it shrinks tumors and delays the time until either tumor progression or death compared with its component drugs alone.

A Bristol-Myers spokeswoman said "long-term survival, which is ultimately our goal and that of patients, should be given appropriate and significant consideration in assessing value." She added that only patients who continue to respond to the therapy stay on treatment.

Other expensive combinations have also hit the market. A two-drug melanoma regimen from Novartis AG costs about $18,869 for a 30-day supply, or roughly $226,428 per patient if taken for a year. A Novartis spokeswoman said studies have shown the combination prolongs patient survival.

The FDA based its approval of the Yervoy-Opdivo combination on a Bristol-funded study that showed the regimen significantly shrank tumors in 60% of melanoma patients, versus 11% of patients receiving Yervoy alone. The median time from start of treatment until disease progression or death--also known as progression-free survival--was 8.9 months among those receiving the combination, versus 4.7 months in the Yervoy-alone group.

"It is the first example of an immuno-oncology treatment that could produce an objective (tumor) response in the majority of patients," said Jedd Wolchok, chief of melanoma and immunotherapies service at Memorial Sloan Kettering Cancer Center, New York, and a leader of several studies of the combined treatments.

The combination also increased the risk of serious adverse events such as the gastrointestinal disorder colitis.

Dr. Wolchok said oncologists in community practices may need some education in managing the side effects, which are different from those resulting from chemotherapy and other cancer drugs. The new combination requires oncologists and nurses "to pay attention to toxicity so it can be reversed quickly," said Dr. Wolchok, who is a consultant for Bristol-Myers and whose institution gets grant support from the company.

A patient receiving the combination therapy takes both drugs for the first 12 weeks and then Yervoy treatment is stopped. The patient continues taking Opdivo until experiencing disease progression or unacceptable toxicity. 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. Subsequent full-year costs of therapy would be about $150,000 for Opdivo alone.

Yervoy, which was introduced in 2011, generated $621 million in sales for Bristol in the first half of this year. Opdivo, launched late last year, had $162 million in sales for the same period.

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 16:29 ET (20:29 GMT)

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