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March 26, 2018

Eisai and Merck get Japanese regulatory approval for Lenvima

Eisai and Merck have received the regulatory approval for the use of Lenvima to treat unresectable hepatocellular carcinoma (HCC) patients in Japan.

Eisai and Merck have received the regulatory approval for the use of Lenvima to treat unresectable hepatocellular carcinoma (HCC) patients in Japan.

According to the companies, Lenvima is the first systemic therapy authorised in the country for the front-line treatment of this type of liver cancer in around ten years.

Lenvima is an oral, inhibitor of multiple receptor tyrosine kinase (RTK) with a unique binding mode.

The drug selectively blocks the kinase activities of vascular endothelial growth factor (VEGF) receptors, VEGFR1, VEGFR2 and VEGFR3, and fibroblast growth factor (FGF) receptors, FGFR1, FGFR2, FGFR3 and FGFR4.

It also prevents additional pathway-related RTKs that are associated with tumour angiogenesis and progression.

Eisai oncology business group chief medicine creation officer Dr Takashi Owa said: “With the approval of this additional indication of unresectable HCC for Lenvima, we are proud to be able to deliver the first new front-line systemic therapy treatment option for HCC in Japan in approximately ten years, and expect this will contribute to HCC treatment.

“With the approval of this additional indication of unresectable HCC for Lenvima, we are proud to be able to deliver the first new front-line systemic therapy treatment option for HCC in Japan in approximately ten years.”

“Eisai will continue with its efforts in oncology research and development in order to deliver hopes for a potential cure for cancer to patients and their families.”

The regulatory approval is based on the results of a Phase III clinical trial where Lenvima achieved statistically significant non-inferiority of overall survival compared to sorafenib.

Similar clinically meaningful improvements were observed in progression-free survival, time to progression and objective response rate.

Currently, Lenvima is available for refractory thyroid cancer treatment in more than 50 countries. It has also been approved to be used with everolimus to treat second-line renal cell cancer in more than 40 markets.

Eisai has also submitted applications for Lenvima as a HCC treatment in the US, Europe, China and Taiwan.

Liver cancer is the second leading cause of cancer-related deaths, with approximately 750,000 deaths per year estimated globally. Approximately 780,000 cases are newly diagnosed each year, 80% of which occur in Asia.

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