FDA Approves Bristol-Myers Squibb’s Opdivo for Lung Cancer

By Ron Winslow

U.S. regulators approved Bristol-Myers Squibb Co. ’s advanced lung cancer drug Opdivo, the latest of a string of events that has focused efforts on using the immune system to battle the disease. The action by the U.S. Food and Drug Administration came three months ahead of the agency’s deadline for reviewing the drug and just two months after a clinical trial of Opdivo was stopped early because of a significant improvement in survival. Lung cancer is the leading cause of cancer death in the U.S.

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The approval amounts to an expanded indication for Opdivo, which was first approved for the market in December for patients with advanced melanoma, a skin cancer. The company plans to price the drug at about $12,500 a month, or $150,000 for patients who stay on it for a year. That is the same price as Bristol-Myers charges for the melanoma treatment.

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Opdivo, also known as nivolumab, and its rivals work by interfering with a molecular brake known as PD-1 that prevents the body’s immune system from attacking tumors. These agents and a similar drug Yervoy, from Bristol-Myers, have excited oncologists partly because many of the advanced cancer patients who are helped experience durable responses much longer than is seen with other treatments.

David Gobin, a retired Baltimore policeman, was treated with the drug in a clinical trial beginning in early 2011, after debilitating courses of chemotherapy failed to contain his lung cancer. The drug eventually melted away nearly all of his cancer and he stopped taking it two years later... But it doesn’t work for everybody. In one of the two trials that were the basis of approval, just 15% of patients responded to the treatment. Still, among patients who benefited, their tumors were shrunk or held at bay for at least six months, the FDA said.

The approval is for patients with a type of cancer called advanced squamous non-small cell lung cancer, which is typically associated with smoking

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http://www.wsj.com/articles/fda-approves-bristol-myers-squibbs-opdivo-for-lung-cancer-1425495157