FDA Approves Two New Indications for Opdivo
The Food and Drug Administration (FDA) has approved Opdivo (nivolumab; Bristol-Myers Squibb) to treat patients with metastatic renal cell carcinoma who have received prior anti-angiogenic therapy and as a single agent to treat patients with BRAFV600 wild-type (WT) unresectable or metastatic melanoma.
The safety and efficacy of Opdivo for renal cell carcinoma were demonstrated in an open-label, randomized study (n=821) of patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an anti-angiogenic drug. Patients were assigned treatment with Opdivo or everolimus (Afinitor; Novartis). Patients treated with Opdivo survived an average of 25 months after starting treatment vs. 19.6 months in patients treated with Afinitor. Also, 21.5% of patients treated with Opdivo experienced a complete or partial shrinkage of their tumors, which lasted an average of 23 months vs. 3.9% of patients treated with Afinitor, which lasted an average of 13.7 months.
The approval for BRAFV600 WT unresectable or metastatic melanoma was based on data from CheckMate -066, a Phase 3, randomized, double-blind study that evaluated overall survival as the primary endpoint in treatment-naive patients with BRAF WT unresectable or metastatic melanoma treated with Opdivo (n=210) vs. dacarbazine (n=208). Treatment with Opdivo demonstrated superior overall survival vs. dacarbazine in the first-line setting. The median overall survival was not reached for Opdivo and was 10.8 months (95% CI: 9.3–12.1) in the dacarbazine arm (HR 0.42, 95% CI: 0.30–0.60; P<0.0001). Also, median progression-free survival was more than double with Opdivo (5.1 months, 95% CI: 3.5–10.8) vs. 2.2 months (95% CI: 2.1–2.4) for patients treated with dacarbazine (HR 0.43, 95% CI: 0.34–0.56; P<0.0001).
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.
Opdivo is available as a 10mg/mL strength solution for IV infusion in 4mL and 10mL single-use vials.
For more information call (855) OPDIVO-1 or visit Opdivo.com.