HLB Advances Cancer Drug Pipeline: Rivoceranib FDA Decision Due March, Plans RLY-4008 Development
Key Insights
Korean pharmaceutical company HLB (search) anticipates FDA approval for Rivoceranib in liver cancer (search) by March 20, with plans to expand its use to adenoid cystic carcinoma (search) through NCCN (search) guidelines.
HLB (search) subsidiary Elevar Therapeutics (search) aims to submit a new drug application for RLY-4008 in bile duct cancer (search) by end of 2024, following successful patient recruitment in clinical trials.
The company is pursuing development of RLY-4008 as a tumor-agnostic drug, following the successful model of Merck (search)'s Keytruda, targeting multiple solid tumor types.
HLB (search), a Korean pharmaceutical company, is poised to strengthen its position in oncology with multiple drug development initiatives planned through 2026. The company's immediate focus is on Rivoceranib, which faces a crucial FDA approval decision for liver cancer (search) treatment on March 20.
The company's strategic roadmap includes expanding Rivoceranib's therapeutic applications. Following successful completion of the world's first Phase 2 clinical trials for adenoid cystic carcinoma (search) (ACC), HLB (search) plans to incorporate Rivoceranib into the U.S. National Comprehensive Cancer Network (NCCN (search)) guidelines as a preferred treatment regimen before initiating Phase 3 trials.
RLY-4008 Development Strategy
HLB (search)'s U.S. subsidiary, Elevar Therapeutics (search), is preparing to file a new drug application (NDA) for RLY-4008 in bile duct cancer (search) by the end of 2024. The drug, originally developed by Relay Therapeutics and licensed to Elevar, shows promise beyond its initial indication.
The company has ambitious plans to develop RLY-4008 as a tumor-agnostic treatment, following in the footsteps of successful precedents like Merck (search)'s Keytruda, which became the industry's leading blockbuster after its approval as the first tumor-agnostic drug in 2017. Tumor-agnostic drugs are unique in their approach, targeting specific biomarkers regardless of the cancer's origin in the body.
Clinical Progress and Future Outlook
Relay Therapeutics' foresight in RLY-4008's potential as a tumor-agnostic therapy led to the inclusion of various tumor types in their Phase 1/2 clinical trials initiated in 2020. Elevar has completed patient recruitment for the bile duct cancer (search) cohort and is expanding enrollment to include additional solid tumor types.
"Based on the prognosis of the patients enrolled so far, we believe RLY-4008 has a strong potential as a tumor-agnostic drug, prompting us to recruit more patients," stated Elevar CEO Chong Sae-ho. He added, "The approval of Rivoceranib as a liver cancer (search) treatment is expected this year, and we are preparing for an NDA for the bile duct cancer (search) treatment this year, reaching a landmark for both the company and patients."