China's NMPA accepts Lenvima sNDA for reviews

Lenvima(lenvatinib), the orally available kinase inhibitor discovered by Japanese pharma major Eisai (TYO: 4523), has been accepted by the National Medical Products Administration (NMPA) of China for an application for the additional indication of differentiated thyroid cancer.

Lenvima was approved in China first as a single agent for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy in September 2018, and launched there in November of that year. Lenvima is expected to bring in annual global revenue of $3.46 billion by 2022, according to Thomson Reuters data.

This application was mainly based on the results of the SELECT Study (Study 303) conducted globally for patients with radioactive iodine-refractory differentiated thyroid cancer. In the SELECT study, Lenvima demonstrated a statistically-significant extension in progression-free survival (PFS), which is the primary endpoint, compared to placebo (median PFS in the Lenvima group: 18.3 months, median PFS in the placebo group: 3.6 months; Hazard Ratio 0.21 [99% CI: 0.14-0.31]; p<0.001). Eisai could submit this application earlier by utilizing the results of SELECT study, while local Phase III clinical trial (Study 308) evaluating Lenvima in patients with radioactive iodine-refractory differentiated thyroid cancer is ongoing in China.

In China, around 190,000 new cases of thyroid cancer are diagnosed each year, and approximately 8,600 are likely to die annually. Although treatment is possible for most types of thyroid cancer, there are few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs.   

In March 2018, Eisai and Merck & Co (NYSE: MRK), known as MSD outside the USA and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima.