EMILIA supports Roche's T-DM1 filing but MARIANNE will be key to market performance
This article was originally published in Scrip
Executive Summary
Roche is planning to file this year for US and EU approval of T-DM1, the antibody drug conjugate version of its breast cancer drug Herceptin, following positive top-line results from a Phase III trial. While the news is welcome, a key uncertainty remains regarding the drug's commercial potential: how it will stack up against Herceptin (trastuzumab) itself. Overall survival data are also yet to be reported.