HLB's 'Lenvatinib' Receives Positive Signal for FDA Approval

Response of "No Problem" in Pre-Review Meeting

HLB logo (Photo by HLB)

[Asia Economy Reporter Chunhee Lee] A positive response has emerged from the U.S. Food and Drug Administration (FDA) regarding the approval of the first-line treatment for liver cancer using HLB's anticancer drug 'Rivoceranib' combined with Hansoh Pharmaceutical's immuno-oncology drug 'Camrelizumab.'

HLB announced on the 17th that it received the minutes of the Pre-New Drug Application (Pre-NDA) meeting held with the FDA along with Hansoh Pharmaceutical on the 11th of last month. The Pre-NDA is a preliminary discussion with the FDA about the new drug application data and content before the NDA submission. However, while Rivoceranib will proceed through the NDA process, Camrelizumab will be processed as a biological license application (BLA) since it is an antibody drug.

HLB stated that the FDA responded through the meeting minutes that there is no issue in proceeding with the NDA and BLA based on the combination clinical results of Rivoceranib and Camrelizumab, particularly focusing on the primary endpoint of overall survival (OS) of patients. They also added that the FDA will conduct a detailed review once the NDA and BLA application materials are submitted.

Regarding safety, it was also mentioned that there are no problems with the safety of adverse events caused by the combination therapy of the two drugs in the NDA and BLA, and detailed matters will be reviewed once the data is submitted.

Previously, the phase 3 clinical trial results of the combination therapy of Rivoceranib and Camrelizumab for liver cancer were presented at the European Society for Medical Oncology (ESMO) in September. The results showed an average overall survival (mOS) of 22.1 months, a milestone never before exceeding 20 months in previous trials. This was significantly better compared to the control group treated with 'Nexavar' (active ingredient Sorafenib), which had 15.2 months. Notably, high efficacy was confirmed not only in patients infected with hepatitis B virus (HBV) but also in those with hepatitis C virus (HCV), the main cause of liver cancer in Western populations, as well as in non-viral patients, indicating broad therapeutic effects regardless of region or cause of onset.

With the official opinion from the FDA received, HLB plans to accelerate the preparation of NDA materials through consultations with its U.S. subsidiary Elevar and Hansoh Pharmaceutical. For the NDA, preparation of various data is required, including data from early research results, nonclinical studies such as toxicity and pharmacology, clinical phases 1 to 3, as well as chemistry, manufacturing, and controls (CMC) documentation.

An HLB official said, “With a sense of mission to bring hope to employees, shareholders, and patients awaiting new treatments, we will do our best to promptly proceed with the NDA.”

This content was produced with the assistance of AI translation services.