The Food and Drug Administration (FDA) has granted Orphan Drug designation to rivoceranib for the treatment of hepatocellular carcinoma (HCC).

Rivoceranib is an orally administered, small molecule inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2). The Company is currently evaluating the treatment in combination with camrelizumab as adjuvant therapy in adults with HCC in two phase 3 studies (ClinicalTrials.gov Identifier: NCT04639180, NCT04985136).

“Unfortunately, HCC is often diagnosed at later stages of disease and there are limited treatment options currently available,” said Maureen G. Conlan, MD, FACP, Chief Medical Officer of Elevar Therapeutics. “We are encouraged by the progress that we are making in our phase 3 clinical trial and believe that the combination of rivoceranib and camrelizumab, if approved, will offer an important new therapeutic option for clinicians and patients.”

Trials investigating rivoceranib for the treatment of gastric cancer, adenoid cystic carcinoma, and colorectal cancer are also underway, according to the Company.


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The FDA’s Orphan Drug designation is granted to medicines intended to treat or prevent rare diseases or disorders that affect fewer than 200,000 individuals.

Reference

Elevar Therapeutics receives Orphan Drug designation from FDA for rivoceranib for the treatment of hepatocellular carcinoma (HCC). News release. Elevar Therapeutics, Inc. Accessed November 11, 2021. https://www.prnewswire.com/news-releases/elevar-therapeutics-receives-orphan-drug-designation-from-fda-for-rivoceranib-for-the-treatment-of-hepatocellular-carcinoma-hcc-301421938.html