HLB's 'Lenvatinib' Targets FDA Approval as First-Line Treatment for Liver Cancer

Hansoh Pharmaceutical Completes Pre-New Drug Application Meeting for 'Camrelizumab' Combination Therapy
"FDA Responded Positively"... Application Expected Within Next Year

[Asia Economy Reporter Chunhee Lee] HLB announced on the 12th that its U.S. subsidiary Elevar and China’s Hansoh Pharmaceutical have completed a Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for the new drug application (NDA) of the combination therapy of 'Lenvatinib' and 'Camrelizumab' as a first-line treatment for hepatocellular carcinoma (HCC). The Pre-NDA is a preliminary discussion session with the FDA regarding related data and content before the NDA submission.

According to HLB, during the meeting held on the 11th (local time), the FDA reviewed the Phase 3 clinical trial results and related data of the Lenvatinib-Camrelizumab combination therapy for first-line HCC treatment and responded positively, stating there were “no issues” with proceeding to the NDA. The company plans to proceed with the NDA soon since the FDA raised no particular objections during the Pre-NDA meeting. The NDA is expected to be submitted as early as the beginning of next year.

The Lenvatinib-Camrelizumab combination therapy demonstrated its potential to become the 'best-in-class' drug by proving efficacy with a median overall survival (mOS) of 22.1 months, surpassing 20 months for the first time, at the European Society for Medical Oncology (ESMO) conference held last month in Paris, France. The control group treated with the existing drug 'Lenvax (generic name Sorafenib)' showed an mOS of only 15.2 months.

Other key indicators such as progression-free survival (PFS) and objective response rate (ORR) also showed higher efficacy compared to the control group. PFS refers to the time from the start of drug treatment until the first confirmation of disease progression. The median PFS (mPFS) was 5.6 months, exceeding the control group’s 3.7 months, and the ORR was 25.4%, higher than the control group’s 5.9%.

HLB explained that high efficacy was confirmed not only in patients infected with hepatitis B virus (HBV) but also in patients infected with hepatitis C virus (HCV), the main cause of liver cancer in Western populations, as well as in non-viral patients, indicating a broad therapeutic effect.

Seho Jung, CEO of Elevar, said, “The FDA positively evaluated the NDA process without requesting additional supplementary data.” He added, “Lenvatinib has proven high efficacy as a liver cancer treatment regardless of cancer causes in multiple countries including the U.S., Europe, and Asia, and we are confident that the new drug approval process will proceed smoothly.”

The NDA for another indication targeted by Lenvatinib, adrenocortical carcinoma treatment, is also progressing rapidly. A meeting with the FDA was held in June after completing Phase 2 clinical trials, and a Breakthrough Therapy designation application was submitted earlier this month. If designated as a Breakthrough Therapy, the FDA’s lead reviewer will actively participate as a partner in the subsequent development process, increasing the likelihood of new drug approval, and the Priority Review system can shorten the usual 10-month review period to about 6 months. HLB plans to submit the NDA for adrenocortical carcinoma within this year.

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