Eisai, Merck announce China approval of liver cancer med

Eisai (ESALY) and Merck (MRK) announced that the China National Medical Products Administration, or NMPA, approved the kinase inhibitor Lenvima as a single agent for the treatment of patients with unresectable hepatocellular carcinoma, or 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. The approval was based on results from the REFLECT study, an open-label, Phase 3 trial where Lenvima demonstrated a treatment effect on overall survival by statistical confirmation of non-inferiority when compared with the standard of care, sorafenib, in 954 patients with previously untreated unresectable HCC; patients randomized to the Lenvima arm did not have a statistically significant improvement in overall survival compared to those in the sorafenib arm.
https://thefly.com/landingPageNews.php?id=2785705