HLB’s liver cancer treatment awarded Orphan Drug Status by FDA
pharmafile | November 8, 2021 | News story | Sales and Marketing |
HLB have announced that its anticancer drug candidate, rivoceranib, has been awarded Orphan Drug Status by the FDA. HLB is conducting a Phase III clinical trial for riboceranib and the immunotherapy drug camrelizumab in combination as first-line treatment of liver cancer.
Rivoceranb is an oral anticancer substance that inhibits vascular endothelial cell receptor (VEGFR)-2, and activates immune cells, by inhibiting angiogenesis and normalising blood vessels. In December 2020, the drug was approved as a second-line therapy for liver cancer in China, and designated an orphan drug by the FDA for gastric cancer in June 2017. It was also designated an orphan drug by the FDA for adenoid cystic cancer in February 2021.
The FDA’s Orphan Drug Designation (ODD) supports the development and evaluation of new treatments for rare diseases. Once designated an orphan drug, the developers can benefit from a reduction in the period of approval and in approval of clinical trials, the exemption of user fees for prescription drugs, tax reduction, and market monopoly rights for 7 years after obtaining ODD approval.
An HLB official stated that: “In addition to the first Phase III trials for liver cancer, we are preparing an application for marketing authorisation (NDA) for riboceranib as a treatment for end-stage gastric cancer.” Clinical studies of rivoceranib conducted in China showed complete remission in hepatocellular carcinoma, the most common form of liver cancer. Complete remission was additionally observed for gastric cancer, lung cancer, esophageal cancer, and T-cell lymphoma.
HLB is a Korean biopharmaceutical company, emerging in research, development and manufacturing. The company is widely known for its anticancer treatments.
Ana Ovey
