Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for the expanded use of Opdivo (nivolumab) in the treatment of hepatocellular carcinoma (HCC) after prior sorafenib therapy. The FDA granted an Orphan Drug designation for Opdivo in the treatment of HCC.

The sBLA submission was based on results from the Phase 1/2 CheckMate -040 study. Patients enrolled in this study had advanced HCC with and without pepatitis B virus or hepatitis C virus infection. The program is designed based on clinical trials of all phases focusing on the use of Opdivo in various tumor types. Findings from this study will be presented at the American Society of Clinical Oncology (ASCO). 

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Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, is currently approved for the treatment of various cancers as both single agent therapy and combination therapy with Yervoy (ipilimumab). Some approved indications include unresectable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC), and advanced renal cell carcinoma, among others. It is available as 10mg/mL strength solution in 4mL and 10mL single-use vials.

The FDA’s action date of this Priority Review is set for September 24, 2017.

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