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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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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