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January 17, 2016

US FDA grants priority review to Eisai’s new drug application for anticancer drug lenvatinib

The US Food and Drug Administration (FDA) has granted priority review status to the supplemental new drug application (sNDA) submitted by Eisai for its anticancer agent lenvatinib mesylate, as a treatment for patients with kidney cancer.

The US Food and Drug Administration (FDA) has granted priority review status to the supplemental new drug application (sNDA) submitted by Eisai for its anticancer agent lenvatinib mesylate, as a treatment for patients with kidney cancer.

The agency has assigned a prescription drug user fee act (PDUFA) action date of 16 May 2016, six months after the submission of the sNDA.

The drug has also received a breakthrough therapy designation from the FDA.

Eisai also submitted an application seeking approval for use in the treatment of renal cell carcinoma in January 2016 in Europe.

"Eisai also submitted an application seeking approval for use in the treatment of renal cell carcinoma in January 2016 in Europe."

The company said it proposes to discuss further steps with regard to submission strategies for the potential indication with Japanese regulatory authorities also.

This sNDA was based on a Phase II clinical study (Study 205)1 that compared the safety as well as efficacy among three groups.

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The groups included a combination of lenvatinib (18mg) plus everolimus (5mg), lenvatinib alone (24mg) and everolimus alone (10mg) in advanced or metastatic renal cell carcinoma.

The results of the study demonstrated an extension in progression free survival (PFS) compared to the everolimus alone group.

Additionally, the lenvatinib alone group demonstrated an extension in PFS compared to the everolimus alone group.

Lenvatinib is already available under the brand name Lenvima in the US, Japan and Europe for use in the treatment of refractory thyroid cancer.

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