Bristol-Myers Squibb Co. said the U.S. Food and Drug Administration granted priority review to its application seeking approval for the combination of its cancer drugs Opdivo and Yervoy as initial treatment for non-small cell lung cancer.
The agency is expected to give its decision May 15, the New York-based pharmaceutical giant said in a Jan. 15 press release.
In its supplemental biologics license application, Bristol-Myers is seeking approval for the Opdivo-Yervoy combination to treat patients with NSCLC whose cancer has spread to another body part or is recurrent and who show no mutations of the EGFR or ALK genes.
The application is based on results from part of the Checkmate-227 phase 3 trial, which showed that the drug combination was better in extending the lifespan of the patients with previously untreated NSCLC whose tumors expressed PD-L1, a protein found on some cancer cells, as compared to chemotherapy. The Opdivo combination also improved the progression-free survival rate in these patients, meeting the second co-primary endpoint of the study.