FDA Reviewing Application for Opdivo Use in Hepatocellular Carcinoma, Often Caused by Hepatitis

FDA Reviewing Application for Opdivo Use in Hepatocellular Carcinoma, Often Caused by Hepatitis

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental Biologics License Application (sBLA) to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC).

People chronically infected with hepatitis B virus (HBV) and hepatitis C virus (HCV) are at increased risk of developing HCC.

The FDA set an action date of Sept. 24, 2017, for a final decision on the application.

“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,” Ian M. Waxman, MD, development lead of gastrointestinal cancers at Bristol-Myers Squibb (Opdivo’s developer), said in a press release.

HCC is the most common type of liver cancer and the fifth most common cancer. More than 700,000 people around the world are diagnosed each year with the cancer. Most cases of HCC are caused by HBV and HCV. These viruses cause liver injury, including fibrosis and chronic inflammation, which favors the malignant transformation of liver cells.

Scientists have worked to identify specific differences between cancer cells and normal cells to develop targeted therapies. They found that some cancer cells display certain molecules at their surface to prevent them from being killed by immune T-cells.

Immune T-cells have checkpoint proteins, such as PD-1, that recognize their ligands in normal cells. This interaction prevents T-cells from harming healthy cells. However, some tumors have high levels of these PD-1 ligands, and therefore compromise what would be an effective anti-tumor immune response by T-cells.

Opdivo blocks the interaction between PD-1 and its ligands, and overcomes the inhibition of anti-tumor immune responses.

The FDA has granted priority review status to the Opdivo application based on the CheckMate 040 Phase 1/2 trial (NCT01658878) in advanced HCC patients with and without HBV or HCV infections.

Results from the trial were recently published in  The Lancet in an article titled “Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial.”

The study shows that Opdivo has a manageable safety profile and acceptable tolerability, supporting the drug’s potential for the treatment of advanced HCC.

So far, Nexavar (sorafenib) was the unique target drug for advanced HCC; now Opdivo may be an option to patients who develop serious adverse side effects or resistance to Nexavar.

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