Following a submission in its native Japan, pharma major Eisai (TYO: 4523) has submitted applications for its in-house discovered and developed anticancer agent lenvatinib mesylate for the treatment of hepatocellular carcinoma (HCC) in both the USA and Europe.
The submissions are based on the results of the REFLECT study, a multicenter, open-label, randomized, global Phase III trial comparing the efficacy and safety of lenvatinib versus sorafenib as a first-line treatment for 954 patients with unresectable HCC.
Sorafenib, marketed by German pharma major Bayer (BAYN: DE) under the name Nexavar, is a standard treatment for HCC.
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