T-DM1 comprises ImmunoGen’s DM1 cancer-cell killing agent linked to the HER2-targeting antibody, trastuzumab, developed by Genentech, a wholly owned member of the Roche Group. T-DM1 is in global development by the Roche Group under a collaboration agreement between Genentech and ImmunoGen.
Reportedly, Roche’s representatives had discussions with the FDA and based on these discussions, Genentech/Roche plans to submit a marketing application to the FDA in 2010 for use of T-DM1 in the treatment of advanced HER2-positive metastatic breast cancer.
The basis for this application is to be the positive Phase II data that were presented at the San Antonio Breast Cancer Symposium in December 2009.
Daniel Junius, president and CEO, said: “We’re pleased that Roche has provided this update and look forward to the submission of the US marketing application for T-DM1.”