EC approval for Lenvima for liver cancer treatment

Eisai and Merck & Co have recently received approval from the FDA to market Lenvima, and now they have received approval from the European Commission to market their RTK inhibitor as a first line treatment for adults who have received no prior systemic therapy for advanced or unresectable hepatocellular carcinoma (HCC). It already has approval for the treatment of thyroid cancer.

HCC is responsible for around 90% of liver cancer cases, which themselves are responsible for around 750,000 deaths a year. Data from the phase III REFLECT study showed that patients taking Lenvima experienced a median overall survival of 13.6 months versus Nexavar, the current treatment option, which had an overall survival rate of 12.3 months. It also showed statistically significant superiority and clinically meaningful improvements versus Nexavar in progression-free survival by 3.7 months.