FDA OKs Bristol Opdivo + Yervoy First-Line in Non-Small Cell Lung Cancer

In CheckMate -9LA, Opdivo + Yervoy combined with two cycles of chemotherapy demonstrated superior overall survival versus chemotherapy, regardless of PD-L1 expression or tumor histology¹

Approval marks sixth indication for Opdivo + Yervoy-based combinations across five types of cancer

Two Opdivo + Yervoy-based combinations are now approved in first-line lung cancer

Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.¹ The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression.¹ This application was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.² On May 15, the FDA approved Opdivo + Yervoy as a first-line treatment for certain patients with metastatic NSCLC whose tumors express PD-L1≥1% as determined by an FDA-approved test.

https://www.marketscreener.com/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-Squibb-U-S-Food-and-Drug-Administration-Approves-Opdivo-nivolumab-Yervoy-ipi-30675868/