Oral RTK inhibitor lenvatinib to treat HCCOctober 10, 2018
The EC has granted a marketing authorization for the oral receptor tyrosine kinase (RTK) inhibitor lenvatinib (Lenvima), as a single agent for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.
Lenvatinib is the first new, first-line treatment for advanced or unresectable HCC in a decade to show an overall survival treatment effect by statistical confirmation of non-inferiority against standard of care, according to a joint press statement by Eisai and Merck.
Lenvatinib’s approval was based on results from REFLECT (Study 304), an open-label, phase 3 trial where the drug 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. Lenvatinib also demonstrated statistically significant superiority and clinically meaningful improvements in progression-free survival and objective response rate.
Currently, Lenvima is marketed in Japan for the treatment of HCC and in the United States for the treatment of first-line unresectable HCC.
In March 2018, Eisai and Merck entered into a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima.