Eisai's Lenvatinib Granted Second Indication in China for Differentiated Thyroid Cancer

On November 9, according to the notice on the issuance of drug approval documents by the National Medical Products Administration (NMPA) of China, Eisai’s lenvatinib received a new approval number. In December last year, the Center for Drug Evaluation (CDE) accepted its marketing application (JXHS1900157 / JXHS1900158) for the treatment of patients with differentiated thyroid cancer (DTC). The acceptance number associated with the newly issued approval number is consistent with that of the marketing application accepted at the end of last year, indicating that lenvatinib has been officially approved in China for the treatment of thyroid cancer!

The marketing application for the new indication of lenvatinib is primarily based on the results of the global SELECT study (Study 303) conducted in patients with radioactive iodine-refractory differentiated thyroid cancer. In the global SELECT study, the primary endpoint was progression-free survival (PFS). The results demonstrated that lenvatinib significantly prolonged PFS compared with placebo, with a statistically significant difference (median PFS: 18.3 months in the lenvatinib group vs. 3.6 months in the placebo group; hazard ratio: 0.21). The results of the Phase 3 Study 308 evaluating the efficacy of lenvatinib in Chinese patients with radioactive iodine-refractory differentiated thyroid cancer are pending publication by Eisai.

In China, there are approximately 190,000 newly diagnosed cases of thyroid cancer and about 8,600 deaths annually. According to data from the National Cancer Center of China, the incidence of thyroid cancer is continuing to rise at an annual rate of 20%. A study published in The Lancet Diabetes & Endocrinology reported that thyroid cancer has a higher incidence among middle-aged women (aged 35–64 years). Based on histological characteristics, thyroid cancer can be classified into differentiated thyroid cancer (DTC) and anaplastic thyroid cancer (ATC). DTC accounts for more than 90% of all thyroid cancers and includes the more common papillary thyroid carcinoma and follicular thyroid carcinoma; patients with early-stage DTC generally have a favorable prognosis. Although most types of thyroid cancer can be treated with appropriate therapies, treatment options become very limited once the disease progresses. Therefore, thyroid cancer remains a condition with significant unmet medical needs.

Lenvatinib is a multi-target tyrosine kinase inhibitor that blocks a series of targets within tumor cells, including VEGFR1-3, FGFR1-4, PDGFRα, KIT, and RET. In February 2015, the drug was approved by the U.S. FDA for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. It was subsequently approved for the treatment of renal cell carcinoma, hepatocellular carcinoma, and endometrial cancer. In September 2018, lenvatinib was officially approved in China for the treatment of unresectable hepatocellular carcinoma in patients who had not previously received systemic therapy.

References:

[1] Announcement on the Availability for Collection of Drug Approval Documents Issued on November 9, 2020. Retrieved 2020-11-09, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20201109130852131.html

Source: Jike Yaowen

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