FDA Approves Eisai and Merck’s Lenvima

FDA has approved Eisai and Merck’s kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on results from REFLECT (Study 304), where Lenvima demonstrated a proven treatment effect on overall survival, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival and objective response rate when compared with sorafenib in patients with previously untreated unresectable HCC, they say. Adverse reactions seen with Lenvima include hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, renal failure or impairment, proteinuria, diarrhea, fistula formation and gastrointestinal perforation, QT interval prolongation, hypocalcemia, reversible posterior leukoencephalopathy syndrome, hemorrhagic events, impairment of thyroid stimulating hormone suppression/thyroid dysfunction, and wound healing complications.