The approval was based on data from a late-stage study showing the drug along with chemotherapy improved event-free survival and pathologic complete response compared to chemotherapy alone in patients with resectable non-small cell lung cancer, the drugmaker said.
Non-small cell lung cancer is the most common form of lung cancer, accounting for about 85% of the estimated 2.2 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.
Opdivo, Bristol's flagship cancer drug that was first approved in 2014, brought in $1.99 billion in sales during company's last reported quarter.
The drug is used in patients with several types of cancer including bladder, lung, blood, head and neck and advanced melanoma. It belongs to a class of drugs designed to help the body's immune system fight cancer by blocking a protein called Programmed cell death protein 1 (PD-1).
By Reuters Staff
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