FDA Accepts Opdivo sBLA for Expanded Indication

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of non-squamous (NSQ) non-small cell lung cancer (NSCLC) in previously treated patients.

This sBLA seeks to expand the current indication for Opdivo in patients with previously treated squamous (SQ) NSCLC. The FDA has also granted this application priority review, and Opdivo Breakthrough Therapy designation for this indication. The submission is based on CheckMate -057, a Phase 3 study that evaluated the survival of patients with NSQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. In the study, Opdivo demonstrated an overall survival benefit.

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Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the FDA as a monotherapy in two cancer indications; for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor, and for the treatment of patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy.

For more information call (800) 321–1335 or visit BMS.com.

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