Elevar Therapeutics Receives Orphan Drug Status from EMA for First-Line Therapy in Unresectable Hepatocellular Carcinoma
Friday, August 02, 2024
Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) for rivoceranib in combination with camrelizumab as a first-line treatment for Unresectable Hepatocellular Carcinoma (uHCC).
Chris Galloway, M.D., senior vice president of clinical and medical affairs, emphasized, “This important designation by the EMA underscores the significant need for new treatments for liver cancer. Orphan designation supports Elevar’s goal to introduce a novel first-line systemic therapy for patients in the EU with hepatocellular carcinoma, a major cause of cancer deaths worldwide.”
To qualify for Orphan designation from the EMA, a medicine must:
- Be intended for treating, preventing, or diagnosing a life-threatening or chronically debilitating disease.
- Address a condition with a prevalence of fewer than 5 in 10,000 individuals in the EU, or the investment required for development must not be justified by potential returns.
- Provide a significant benefit to patients if a satisfactory method of diagnosis, prevention, or treatment exists.
The Orphan designation provides incentives such as centralized authorization across EU Member States and 10 years of market exclusivity post-approval.
Each year, over 800,000 people worldwide are diagnosed with liver cancer, which results in more than 700,000 deaths annually. Hepatocellular Carcinoma (HCC) is the most prevalent form of primary liver cancer and often arises in individuals with chronic liver inflammation. HCC typically has a poor prognosis with limited treatment options, indicating a critical need for new therapies.
Rivoceranib is a small-molecule tyrosine kinase inhibitor (TKI) that targets vascular endothelial growth factor receptor (VEGFR), which plays a crucial role in tumor blood vessel formation. It is under investigation for multiple cancers, including uHCC (in combination with camrelizumab), gastric cancer (both as a single agent and with paclitaxel), adenoid cystic carcinoma, and colorectal cancer (with Lonsurf®). Approved in China for advanced gastric cancer and uHCC, rivoceranib has been well-tolerated in clinical trials, showing a safety profile consistent with other TKIs and VEGF inhibitors.
Camrelizumab (SHR-1210) is a monoclonal antibody targeting the PD-1 receptor, a key component in immune checkpoint inhibition. Developed by Hengrui Pharma, it is being tested in over 50 clinical trials for various cancers. In China, it is approved under the name AiRuiKa® for multiple indications, including HCC (second-line) and uHCC (first-line in combination with rivoceranib). In October 2023, Elevar licensed camrelizumab for global marketing outside Greater China and Korea.
Source: elevartherapeutics.com
