FDA grants orphan drug status to rivoceranib for hepatocellular carcinoma
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The FDA granted orphan drug designation to rivoceranib for the treatment of hepatocellular carcinoma.
Rivoceranib (Elevar Therapeutics) is a small-molecule tyrosine kinase inhibitor that targets the VEGF receptor 2, a primary pathway for tumor angiogenesis.
Rivoceranib is under investigation as monotherapy, as well as in combination with immunotherapy and chemotherapy.
A phase 3 trial is assessing the combination of rivoceranib and camrelizumab (Jiangsu Hengrui Medicine) — an anti-PD-1 immune checkpoint inhibitor — for patients with advanced HCC who have not received prior systemic therapy.
“The orphan drug designation granted by the FDA recognizes the potential of rivoceranib to address the urgent unmet need for new therapies that can improve patient outcomes for people with HCC,” Kate McKinley, CEO of Elevar Therapeutics, said in a company-issued press release. “The medical community is eager to see the results of clinical trials exploring new combination regimens in HCC.”
Other studies are underway to evaluate the agent as a potential therapy for colorectal cancer, adenoid cystic carcinoma and gastric cancer.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
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