FDA Approves New Indication for Opdivo
The Food and Drug Administration (FDA) has expanded the indication of Opdivo (nivolumab; Bristol-Myers Squibb) to include patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
The expanded approval was based on data from a randomized trial of 272 patients receiving either Opdivo or docetaxel (Taxotere; Sanofi Aventis); patients receiving Opdivo had greater overall survival compared to those taking docetaxel (3.2 additional months). In a single-arm trial of 117 patients who had progressed after receiving a platinum-based therapy and at least one additional systemic regimen, 15% of participants experienced objective response rate (ORR), of whom 59% had response durations of six months or longer.
Opdivo, a human programmed death receptor-1 (PD-1) blocking antibody, is already indicated for treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
For more information visit FDA.gov.