ImmunoGen Inc Announces Approval of Roche Holding AG's Kadcyla in European Union


Wednesday, 20 Nov 2013 01:10am EST 

ImmunoGen Inc announced that the European Commission has granted marketing approval for Kadcyla (trastuzumab emtansine; ado-trastuzumab emtansine in the US) in the European Union (EU). This event triggers a $5 million milestone payment to ImmunoGen. Kadcyla has been approved for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin (trastuzumab) and a taxane, separately or in combination. Patients should have either: (1) received prior therapy for locally advanced or metastatic disease or (2) developed disease recurrence during or within six months of completing adjuvant therapy. Kadcyla consists of Roche Holding AG's trastuzumab antibody with ImmunoGen`s DM1 cytotoxic agent attached using one of ImmunoGen's engineered linkers. Roche has global development and commercialization rights for Kadcyla; ImmunoGen is entitled to receive royalties on product sales as well as specified milestone payments. 

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