Results

Eisai plots new drug applications in US, Europe and China after Lenvima scores in head-to-head liver cancer study

Haruo Naito, Eisai CEO

Eisai says that its cancer drug Lenvima (lenvatinib) hit the primary endpoint in a Phase III study for first-line use against liver cancer, proving non-inferior to Nexavar. That success, the company adds, will set up regulatory filings in the US, Europe and Asia.

Already approved for kidney cancer, Tokyo-based Eisai says their drug scored on the overall survival rate, testing it in a study with 954 patients. And investigators added that the drug also hit on a slate of secondary endpoints including progress-free survival, time to progression and the objective response rate.

Liver cancer is a particularly big problem in China, where Eisai plans to roll out an application in the near future.

Last summer Eisai partnered with Novartis’ powerhouse marketing team in the US, looking to co-promote this drug, which is already approved for kidney cancer in combination with Afinitor. Its ongoing development plan includes studies for biliary tract cancer and in combination with pembrolizumab for various types of cancer. In addition, Eisai has launched a Phase III clinical study of lenvatinib in combinations with both pembrolizumab and everolimus in renal cell carcinoma for first-line use.


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RAPS Regulatory Convergence 2017