FDA Approves New Indication for Opdivo

FDA Approves New Indication for Opdivo
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.

RELATED: Opdivo Granted Accelerated FDA Approval for Melanoma

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.

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