Drug Profile

Rivoceranib - HLB

Alternative Names: Aitan; Apatinib; Apatinib mesylate; Apatinib Mesylate Tablets; YN-968-D1

Latest Information Update: 23 Oct 2024

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At a glance

Originator Advenchen Laboratories LLC
Developer Elevar Therapeutics; Henan Cancer Hospital; HLB LifeScience; Hunan Cancer Hospital; Jiangsu Hengrui Medicine Co.; Peking University
Class Amides; Antineoplastics; Cyclopentanes; Nitriles; Pyridines; Small molecules
Mechanism of Action Vascular endothelial growth factor receptor-2 antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Gastric cancer; Liver cancer; Adenoid cystic carcinoma
New Molecular Entity Yes

Marketed Gastric cancer; Liver cancer
Phase III Fallopian tube cancer; Non-small cell lung cancer; Ovarian cancer; Peritoneal cancer
Phase II Adenoid cystic carcinoma; Breast cancer; Cholangiocarcinoma; Colorectal cancer; Lung cancer; Malignant melanoma; Osteosarcoma; Small cell lung cancer; Soft tissue sarcoma; Solid tumours; Triple negative breast cancer; Uterine cancer
No development reported Oesophageal cancer

21 Oct 2024 FDA assigns PDUFA action date of (20/03/2025) for rivoceranib for Liver cancer (Combination therapy, First-line therapy, Late-stage disease)
21 Oct 2024 US FDA accepts New Drug Application (NDA) resubmission for rivoceranib for Liver cancer (Combination therapy, First-line therapy, Late-stage disease) for review
23 Sep 2024 Elevar Therapeutics resubmits a New Drug Application (NDA) to the US FDA for rivoceranib in combination with camrelizumab as a first-line systemic treatment option for unresectable Hepatocellular carcinoma (uHCC)

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