(Bloomberg)--Bristol-Myers Squibb Co.’s immune cancer therapy won approval from U.S. regulators for a broader population of lung cancer patients, a boost for a drug that’s expected to become a blockbuster.

The decision by the Food and Drug Administration came almost three months ahead of schedule, following a trend of quicker clearances for new cancer drugs by the agency.

In March, Opdivo was approved three months ahead of plan for use in patients with advanced squamous, non-small cell lung cancer whose disease had progressed during or after trying chemotherapy.

The latest approval is for non-squamous, non-small cell lung cancer whose disease has progressed during or after chemotherapy. The non-squamous form of the cancer accounts for about 45 percent to 60 percent of lung cancer cases.

For the average U.S. patient, Opdivo costs about $12,500 a month, or $150,000 for a year of therapy, a Bristol-Myers spokeswoman said.

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Opdivo was also approved last week for use in combination with another immune therapy drug in a form of melanoma. That combination will cost $256,000, on average, for a year of treatment.

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Opdivo targets a cellular pathway known as PD-1, which restricts the body’s immune system from attacking cancer cells. The drug is expected to expand from $2.15 billion of sales in 2016 to $5.27 billion in 2018, according to analysts’ estimates compiled by Bloomberg.

Instant Insights /

FDA approves Bristol-Myers drug for wider use in lung cancer

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