Bristol-Myers Squibb announced that the Food and Drug Administration (FDA)  has approved Opdivo (nivolumab) in combination with Yervoy(ipilimumab; Bristol-Myers Squibb) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. It has also approved Opdivo as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients. 

Opdivo, a human programmed death receptor-1 (PD-1)-blocking antibody, is already indicated for unresectable or metastatic melanoma and disease progression following ipilimumab. And if BRAF V600 mutation positive, a BRAF inhibitor; and for metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

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The expanded approval was based on data from CheckMate -067, a Phase 3, double-blind, randomized study (n=945) where PFS and overall survival (OS) were co-primary endpoints. It evaluated the efficacy and safety of Opdivo as both a single-agent and as well as in combination with Yervoy vs. Yervoy alone in patients with previously untreated advanced melanoma, including both BRAF V600 mutant and wild-type advanced melanoma. 

Study reults showed a statistically significant improvement in PFS in patients treated with Opdivo + Yervoy (P<0.0001) and with Opdivo alone (P<0.0001) vs. Yervoy alone. Median PFS was 11.5 months (95% CI: 8.9–16.7) for the Opdivo + Yervoy and 6.9 months (95% CI: 4.3–9.5) for Opdivo alone, vs. 2.9 months (95% CI: 2.8–3.4) for Yervoy alone. The Opdivo + Yervoy arm demonstrated a 58% reduction in the risk of disease progression vs. Yervoy (HR: 0.42; 95% CI: 0.34–0.51; P<0.0001), while Opdivo alone demonstrated a 43% risk reduction vs. Yervoy alone (HR: 0.57; 95% CI: 0.47–0.69; P<0.0001).

These indications were approved under accelerated approval. Continued approval for these indications maybe contingent on verification and description of clinical benefit in confirmatory trials. 

Opdivo is available as a 10mg/mL strength solution for IV infusion in 4mL and 10mL single-use vials.

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