FDA Accepts Supplemental Biologics License Application for Nivolumab in Patients With Previously Untreated Advanced Melanoma


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The U.S. Food and Drug Administration (FDA) has accepted for filing and review Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for nivolumab ­(Opdivo) for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted Priority Review for this application. The projected FDA action date is August 7, 2015.

The programmed cell death protein-1 (PD-1) immune checkpoint inhibitor nivolumab was first approved by the FDA in December 2014 for patients with unresectable or metastatic melanoma and disease progression following ipilimumab (Yervoy) and, if BRAF V600–mutation positive, a BRAF inhibitor. This initial indication was approved under accelerated approval based on tumor response rate and durability of response from CheckMate-037 clinical trial results.

The new sBLA accepted by the FDA includes data from CheckMate-066, which evaluated nivolumab in treatment-naive patients with BRAF–wild-type advanced melanoma as compared to dacarbazine chemotherapy. In the trial, safety and tolerability were well characterized, with fewer treatment-related grade 3/4 adverse events observed with nivolumab than dacarbazine.

Use in Other Cancers

Nivolumab is also approved in lung cancer: On March 5, 2015, the drug received FDA approval for the treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Bristol-Myers Squibb has a broad, global development program to study nivolumab in multiple tumor types consisting of more than 50 trials, in which more than 7,000 patients have been enrolled worldwide.  ■

 



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