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FDA grants priority review to Opdivo for small cell lung cancer
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The FDA granted priority review designation to nivolumab for the treatment of patients with small cell lung cancer whose disease progressed after two or more lines of therapy, according to the manufacturer.
Nivolumab (Opdivo, Bristol-Myers Squibb) is a PD-1 immune checkpoint inhibitor.
The FDA based this designation on safety and efficacy data from the small cell lung cancer cohort of the CheckMate 032 trial, which assessed nivolumab alone or with ipilimumab (Yervoy, Bristol-Myers Squibb) among patients with advanced or metastatic solid tumors.
“Small cell lung cancer is a highly aggressive disease, one [in which] most patients experience relapse within a year of diagnosis,” Sabine Maier, development lead of thoracic cancers at Bristol-Myers Squibb, said in a company-issued press release. “The overall prognosis for this cancer remains poor, and there have been no new treatment advances in nearly 20 years. We are pleased with this important step forward in the FDA’s consideration to expand the use of Opdivo to patients with small cell lung cancer who have received two or more lines of previous treatment.”
The FDA set an action date of August 16.