Policy & Regulation
US FDA accepts Bristol-Myers Squibb's supplemental Biologics License Application for Opdivo in combination with Yervoy
17 January 2020 -

The United States Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for United States-based Bristol-Myers Squibb's Opdivo (nivolumab) in combination with Yervoy (ipilimumab) intended for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations, it was reported yesterday.

The application is based on data from part one of the phase three CheckMate -227 trial assessing Opdivo and Yervoy compared to chemotherapy in patients with earlier untreated NSCLC, in which the dual immunotherapy combination indicated significant improvement in overall survival compared to chemotherapy alone.

Sabine Maier, MD, development lead, thoracic cancers, Bristol-Myers Squibb, said, 'The FDA's acceptance of our application for Opdivo plus Yervoy represents an important milestone for patients with lung cancer in the United States, where, despite recent treatment advances, lung cancer remains the cause of more than 150,000 deaths each year. Lung cancer is the third tumour type where the combination of Opdivo and Yervoy has demonstrated significant long-term overall survival benefit in a randomised Phase 3 trial, which further validates the immunologic rationale for dual Immuno-Oncology therapy.'