HLB "Lenvatinib Approved for Treatment Use in Advanced Gastric Cancer Patients"

[Asia Economy Reporter Hyunseok Yoo] HL Biotech's targeted anticancer drug, Rivoceranib, has opened the door to being used as a treatment for terminal gastric cancer patients in South Korea who have failed standard therapies. HL Biotech Life Science, which holds the domestic rights to Rivoceranib, received approval from the Ministry of Food and Drug Safety (MFDS) for 'clinical trial drug use for treatment purposes,' allowing the drug to be used as a treatment in domestic medical settings independently of the new drug approval process.

On the 21st, the MFDS registered HL Biotech's targeted anticancer drug 'Rivoceranib' in the Integrated Drug Information System under the status of ‘approval for use for treatment purposes.’ As a result, Rivoceranib can now be prescribed at authorized hospitals for the treatment of terminal gastric cancer patients.

The ‘approval for use for treatment purposes’ is a system by which the MFDS permits the use of investigational drugs for patients whose lives are at risk but who have no appropriate treatment options. Terminal gastric cancer patients can now choose Rivoceranib, which has not yet received new drug approval, as a new treatment option following this approval.

HL Biotech completed a global Phase 3 clinical trial last June involving terminal gastric cancer patients at 88 general hospitals across 12 countries worldwide. The company is currently preparing to apply for marketing authorization. Additionally, global clinical trials are underway for various indications including liver cancer, cholangiocarcinoma, and colorectal cancer.

An HL Biotech official stated, “Terminal gastric cancer patients and their families often inquire about Rivoceranib prescriptions, but the company had no appropriate way to assist, which was always regrettable. We are very pleased that this approval for use for treatment purposes has opened the way for patients suffering without alternative treatments to receive Rivoceranib prescriptions.” The official added, “As an oral formulation, Rivoceranib has clear advantages in dosing convenience and fewer side effects, and we expect it to significantly improve patients' quality of life.”