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Eisai’s Lenvima wins European liver cancer indication

EC green-lights the RTK inhibitor as a first-line treatment

Eisai

Japanese pharma group Eisai and partner Merck & Co have received a nod from the European Commission (EC) to market its anti-cancer drug Lenvima to treat a certain type of liver cancer.

It is now set as a first-line treatment for adults who have received no prior systemic therapy for advanced or unresectable hepatocellular carcinoma (HCC), a type of liver cancer that accounts for up to 90% of liver cancer cases.

Liver cancer is the second leading cause of cancer-related death, estimated to be responsible for 750,000 deaths annually, and according to the company, treatment options for unresectable HCC are limited and the prognosis is poor.

Lenvima however, is already on the European market to treat thyroid cancer, but thanks to positive data from the phase III REFLECT study, Eisai can now add another string to the drug’s bow.

Achieving its primary endpoint, data demonstrated that patients taking the RTK inhibitor experienced a median overall survival of 13.6 months.

The drug was compared to Bayer’s Nexavar – the current standard of care for HCC patients –which saw an overall survival rate of 12.3 months.

Additionally, Lenvima also demonstrated statistically significant superiority and clinically meaningful improvements compared to Nexavar in progression-free survival (7.3 months versus 3.6 months).

It becomes the first new first-line treatment option for advanced or unresectable HCC to be approved in Europe in approximately ten years.

The companies also just received the go-ahead to market the drug in the US, following a Food and Drug Administration (FDA) approval earlier this week.

Article by
Gemma Jones

23rd August 2018

From: Regulatory

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