FDA Approves Two New Indications for Opdivo

FDA Approves Two New Indications for Opdivo
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 (AfinitorNovartis). 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. 

RELATED: Opdivo Granted Priority Review for Advanced Renal Cancer 

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.

Loading links....