Lenvatinib Submits Second Indication for Marketing Approval in China Targeting Thyroid Cancer

By Cai Cai

As one of Eisai’s most profitable drugs, lenvatinib has captured significant industry attention since its approval for launch in China in September 2018, achieving monthly sales of RMB 100 million and demonstrating remarkable efficacy when combined with PD-1 inhibitors.

On December 7, the marketing application for the second indication of lenvatinib (acceptance numbers: JXHS1900157, JXHS1900158) was submitted to the Center for Drug Evaluation (CDE) and accepted.

(Source: CDE)

The author speculates that the second indication may be thyroid cancer.

In January 2016, the NMPA approved a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial of lenvatinib in China for the treatment of radioactive iodine (I-131)-refractory differentiated thyroid cancer. The clinical trial is currently ongoing.

(Source: Drug Clinical Trial Registration and Information Publicity Platform)

In addition, clinical trials of the combination therapy of lenvatinib and pembrolizumab (Keytruda) for first-line treatment of endometrial cancer, NSCLC, and liver cancer have been conducted in China, all of which have entered Phase III.

(Source: Drug Clinical Trial Registration and Information Publicity Platform)

In September 2019, the FDA approved Keytruda in combination with lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have experienced disease progression following prior systemic therapy and are not candidates for curative surgery or radiation therapy. Previously, the combination of Keytruda and lenvatinib had received Breakthrough Therapy Designation from the FDA as a first-line treatment for renal cell carcinoma, endometrial carcinoma, and hepatocellular carcinoma.

Significantly Prolong Overall Survival (OS) in Chinese Patients with Liver Cancer

Lenvatinib Mesylate Capsules (Lenvatinib, code: E7080) is a multi-target, oral tyrosine kinase inhibitor that targets vascular endothelial growth factor receptors (VEGFR) 1-3, fibroblast growth factor receptors (FGFR) 1-4, RET, KIT, and platelet-derived growth factor receptor β (PDGFRβ).

Lenvatinib has been approved in multiple countries and received approval for marketing in China last year. It is indicated as a monotherapy for the first-line treatment of unresectable hepatocellular carcinoma in patients who have not previously received systemic therapy, becoming the second first-line therapeutic agent for hepatocellular carcinoma after sorafenib. The dosage strength is 4 mg.

(Compiled from public sources)

Lenvatinib Can Significantly Improve Overall Survival (OS) in Chinese Patients with Hepatocellular Carcinoma.

At the CSCO in September 2017, clinical data on lenvatinib for Chinese liver cancer patients were announced.The median overall survival (OS) in the lenvatinib group was as high as 15.0 months, compared to only 10.2 months in the sorafenib group, representing an increase of 4.8 months.

(Data source: The Lancet)

The primary reason for the aforementioned differences in efficacy lies in the fact that lenvatinib demonstrates particularly outstanding therapeutic effects in hepatitis B virus (HBV)-associated hepatocellular carcinoma (HCC), whereas over 90% of HCC cases in China are caused by HBV infection. It can be said that lenvatinib is a targeted therapy specifically tailored for Chinese patients with HCC.

2019 Sales Projected at RMB 800–1,000 Million

Lenvatinib is currently priced at RMB 16,800 per box, with each box containing 30 capsules of 4 mg each. Within two months of its launch in China, sales reached RMB 200 million, and domestic sales for 2019 are projected to be between RMB 800 million and RMB 1 billion. Unfortunately, like its partner MSD, it was not included in the current National Reimbursement Drug List.

CTTQ Becomes First to File for Production of Generic Lenvatinib

Eisai has filed multiple patents for lenvatinib in China, most of which have been granted, while some have not yet entered the country. Core patents, including those for the compound and crystal forms, are set to expire in 2021 and 2024, respectively.

In June 2019, Chia Tai Tianqing submitted a marketing application for lenvatinib under the New Category 4 pathway, becoming the first pharmaceutical company to file for generic production approval.

(Source: CDE)

Original Title: Indication | Lenvatinib, a Blockbuster Drug for Liver Cancer, Submits Application for Its Second Indication! Domestic Sales in 2019 Are Expected to Exceed 800 Million Yuan