U.S. Approves Skin Cancer Treatment

U.S. regulators Monday approved Bristol-Myers Squibb Co. ’s Opdivo for advanced skin cancer, the latest drug to reach the market in the emerging field of cancer immunotherapy.
The decision by the Food and Drug Administration means Bristol-Myers now has two drugs on the market that work by unleashing the body’s immune system to attack tumors, helping to solidify the company’s lead in an area of cancer treatment that has drawn wide interest across the pharmaceutical industry.
It also comes amid a flurry of year-end drug approvals by the federal agency, including three last Friday. Opdivo, which is also known by the chemical name nivolumab, is the eighth new drug to reach the market in the past four years for late-stage melanoma, a historically lethal disease.
Bristol-Myers officials said the company plans to charge an average of $12,500 a month for the treatment, the same price as the rival drug Keytruda from Merck & Co., which was approved in September. Both drugs target a protein called PD-1, a molecular brake that prevents the immune system from seeing tumors as invaders and enables cancer to avoid attack.
The two drugs are approved for patients who fail to respond to certain other medicines including Yervoy, another Bristol-Myers immunotherapy drug that was approved for advanced melanoma in 2011 and that works by releasing a different immune system brake.
All three drugs belong to a class of agents known as checkpoint inhibitors that, by unleashing an immune system attack against cancer, are enabling significant numbers of patients to live years longer than would otherwise be expected. Roche Holding AG and AstraZeneca PLC are among other companies testing agents against immune system brakes.
Approval of Opdivo “is a confirmation of the strength of our strategy” to focus the company’s efforts on cancer immunotherapy, said Giovanni Caforio, Bristol-Myers’s chief operating officer. “The ability to come to the market with a second very important medicine is something we’ve been working for and we’re very proud of it.”
The approval, which came under the FDA’s so-called breakthrough designation initiative, was based on the experience of 120 participants in a continuing clinical trial, among whom 32% had significant tumor shrinkage. The effect lasted for more than six months in about one-third of such patients, the FDA said.
The most serious side effects included a severe immune response against healthy organs, including the lung, and were generally managed by using aggressive treatment with steroids.