US regulators will undertake a speedy review of Bristol-Myers Squibb’s application to expand use of its immunotherapy Opdivo to include to include certain patients with liver cancer.
The firm is seeking approval to market the drug for patients with hepatocellular carcinoma (HCC) who have already received treatment with sorafenib (Bayer’s Nexavar).
The submission includes data from the Phase I/II CheckMate -040 study investigating Opdivo (nivolumab) in advanced HCC patients with and without hepatitis B virus or hepatitis C virus infections.
According to the data, the objective response rate was 20 percent in patients treated with the drug in the dose-expansion phase and 15 percent in the dose-escalation phase of the trial.
“We believe the FDA acceptance of our application for Opdivo with priority review status is an important recognition of the significant unmet need for patients with HCC, which is often diagnosed in the advanced stage when treatment options are limited,” said Ian M. Waxman, development lead, Gastrointestinal Cancers, BMS.
The priority review means that the US Food and Drug Administration should reach a decision on the drug, which has already been awarded orphan status for this indication, by September 24 this year.
More than 700,000 people around the world, including about 40,000 people in the US, are diagnosed with HCC each year. The majority of cases are caused by HBV or HCV infections.
Opdivo is a PD-1 immune checkpoint inhibitor, already approved in the US for certain patients with melanoma, non-small cell lung cancer, renal cell carcinoma and classical Hodgkin lymphoma, and is being assessed in various different tumour types.