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Re: DewDiligence post# 217757

Thursday, 08/16/2018 4:23:01 PM

Thursday, August 16, 2018 4:23:01 PM

Post# of 253171
MRK/Eisai—FDA approves Lenvina monothearpy in first-line HCC:

https://www.prnewswire.com/news-releases/eisai-and-merck-announce-fda-approval-of-lenvima-lenvatinib-capsules-for-first-line-treatment-of-unresectable-hepatocellular-carcinoma-hcc-300698572.html

The approval is based on a head-to-head trial in which Lenvina was non-inferior to Nexavar on OS and superior on PFS and ORR.

Lenvina was previously approved in the US as monotherapy for thyroid cancer and in combination with everolimus for second-line RCC.

The collaboration between Eisai and MRK was inked in Mar 2018 (#msg-139112383).

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