Hot Off The Press T-DM1

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ImmunoGen, Inc. Announces Favorable Update Provided by Roche Related to Its Trastuzumab-DM1 Regulatory Plans
Press Release Source: ImmunoGen, Inc. On Thursday April 15, 2010, 1:01 am EDT
WALTHAM, Mass.--(BUSINESS WIRE)--ImmunoGen, Inc. (Nasdaq: IMGN - News), a biotechnology company that develops targeted anticancer products, today announced that Roche has provided a favorable update related to its plans to apply for marketing approval of trastuzumab-DM1 (T-DM1) in the US.
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.
In its quarterly release issued earlier today, Roche disclosed that company representatives have had discussions with the US Food and Drug Administration (FDA) and that, 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. This is cancer that has progressed on multiple prior therapies including trastuzumab- and lapatinib-containing regimens for metastatic disease. 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.
“We’re pleased that Roche has provided this update and look forward to the submission of the US marketing application for T-DM1,” commented Daniel Junius, President and CEO.