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

Eisai

January 25, 2017

Eisai says that its can­cer drug Lenvima (lenva­tinib) hit the pri­mary end­point in a Phase III study for the treatment of liver can­cer, prov­ing non-in­fe­rior to Nex­avar. That suc­cess will set up reg­u­la­tory fil­ings in the US, Eu­rope and Asia, the com­pany adds. Liver can­cer is a par­tic­u­larly big prob­lem in China, where Eisai plans to roll out an ap­pli­ca­tion in the near fu­ture.

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

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

Eisai plots new drug applications in US, Europe and China after Lenvima scores in head-to-head liver cancer study last edit: 2017-01-25T16:27:38+00:00 da Luca

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