5 September 2018 - First approval for Lenvima in China and first new therapy for the first-line treatment of unresectable hepatocellular carcinoma approved in China in a decade.
Eisai and Merck announced today that the China National Medical Products Administration approved the kinase inhibitor Lenvima (lenvatinib) as a single agent for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. In China, the application of Lenvima was submitted in October 2017 and was designated for priority review by the NMPA due to Lenvima's significant clinical benefit compared to existing treatments, leading to approval in approximately 10 months.
This approval marks the first for Lenvima in China, where the incidence of HCC is high, and the first new systemic therapy approved for the first-line treatment of unresectable HCC in China in ten years.