Eisai/Merck & Co’s Lenvima approved in EU for first line liver cancer

The European Commission has approved Eisai/Merck & Co’s Lenvima as a new first-line treatment for liver cancer. Eisai and Merck & Co, known as MSD outside the US, said approval for Lenvima (lenvatinib) came through an open-label phase 3 trial, Reflect, demonstrating a treatment effect on overall survival (OS). It was deemed non-inferior to the standard of care drug, Nexavar (sorafenib). Also, the trial results confirmed that Lenvima showed a significant superiority and clinically meaningful improvements in progression-free survival (PFS) and objective response rate (ORR) in adults with previously untreated unresectable hepatocellular carcinoma. Those treated with Lenvima experienced a median OS of 13.6 months compared to 12.3 months with sorafenib. The median PFS was 7.3 months versus 3.6 months. The drug is an oral receptor tyrosine kinase (RTK) inhibitor, which works by disrupting the behavior of cancer cells.