Buoyed By T-DM1 EMILIA Data, Roche Leaps To Early Breast Cancer Trial
This article was originally published in The Pink Sheet Daily
In Phase III EMILIA study, Herceptin-containing antibody drug conjugate demonstrates three-month progression-free survival benefit, trend toward overall survival and, importantly, better safety profile. Results pave way for new trials in earlier disease using new FDA approval pathway.
You may also be interested in...
The biotech is fresh off the approval of a highly anticipated breast cancer treatment, which oncology powerhouse Roche/Genentech is commercializing, but investors are already shifting their focus to the company’s lead asset, which has been made riskier by the appearance of a safety signal in Phase II.
Genentech’s HER2 program director Dietmar Berger shares broader plans for Kadcyla (ado-trastuzumab emtansine) following its approval in second-line mBC, and expects Herceptin will continue to play a role in the long term.
Roche is set to launch T-DM1 at the price of $9,800 a month, similar to cost of the preferred first-line regimen, which includes a combination of its own Perjeta and Herceptin. Drug was tested mostly in second-line+ mBC, but labeling allows first-line treatment in a subset of patients at high risk.