Bristol-Myers Drug Approved by FDA for Wider Lung Cancer Useby
Opdivo previously also approved in melanoma combination
Therapy expected to be blockbuster in coming years for company
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.
The approval for a broad segment of patients could give Opdivo an advantage over a competitor, Merck & Co.’s Keytruda, Bloomberg Intelligence analyst Asthika Goonewardene said in a note. The FDA approved Merck’s drug earlier this month for lung cancer, but only for people whose tumors express a protein called PD-L1.
“We believe that testing for the PD-L1 biomarker can provide important information that will help guide treatment decisions for patients with metastatic non-small cell lung cancer,” said Frank Clyburn, president of Merck’s oncology unit, in a statement.
Bristol-Myers shares rose 1.5 percent to $61.44 at the close in New York, while Merck was little changed at $50.95.
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, for an average-sized patient, for a year of treatment.
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.