Regulators are to review Bristol Myers Squibb's application to widen labels for a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for some patients with non-small cell lung cancer (NSCLC).
The company is seeking permission on both sides of the Atlantic to use the drug for first-line treatment of metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumour aberrations.
The applications are based on data from the Phase III CheckMate-9LA trial, which evaluated Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) alongside two cycles of chemotherapy for the first-line treatment of advanced NSCLC and met its primary endpoint in showing a significant improvement in overall survival (OS).
“Despite treatment advances, there remains a serious unmet need for additional innovative treatment options for lung cancer patients globally,” said Sabine Maier, development lead, thoracic cancers, at BMS.
“The FDA’s acceptance and EMA’s validation of our applications represent important milestones for patients with lung cancer, and we look forward to working with regulatory authorities to bring the first and only dual immunotherapy plus limited chemotherapy regimen to patients as soon as possible.”