WASHINGTON (AP) – The Food and Drug Administration on Wednesday expanded approval of an innovative Bristol-Myers Squibb drug to treat the most common form of lung cancer.
Regulators cleared Opdivo for patients with advanced squamous non-small cell lung cancer, which accounts for seven out of eight lung cancer patients. Lung cancer is the leading cause of cancer death in the U.S., responsible for over 159,260 deaths last year.
The drug is part of an innovative new class of medicines, mostly still experimental, called immuno-oncology drugs. The drug works by blocking a protein called PD-1, which prevents the body’s immune system from attacking cancer cells. The latest indication is intended for lung cancer patients who have previously been treated with platinum-based chemotherapy.
The FDA first approved Bristol’s drug in December for melanoma, the deadliest form of skin cancer.
Bristol-Myers won approval for the new indication based on a study of 272 patients in which those receiving Opdivo lived about three months longer than those receiving an older chemotherapy drug.
The most common side effects seen in company studies included fatigue, shortness of breath, decreased appetite, cough and nausea.
Evercore ISI analyst Mark Schoenebaum said in an investment note that Opdivo could garner sales of $1 billion to $1.5 billion for lung cancer in the U.S. and Europe.
The FDA noted that it approved the drug more than three months ahead of its review target, June 22.
Shares of Bristol-Myers Squibb Co. rose $2.53, or 4.1 percent, to $64.45 in afternoon trading.