ImmunoGen Reports Positive Decisions For Kadcyla In EU & Japan - Quick Facts

(RTTNews) - ImmunoGen Inc. (IMGN) announced that the Committee for Medicinal Products for Human Use, or CHMP, has recommended approval of Kadcyla for the treatment of adults with HER2-positive, inoperable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. A decision by the European Commission is expected by year end. An approval decision would trigger a $5 million milestone payment to ImmunoGen.

The company also reported that the Japanese Ministry of Health, Labor and Welfare has approved Kadcyla for the treatment of inoperable or recurrent HER2-positive breast cancer. This event triggers a $5 million milestone payment to ImmunoGen.

Kadcyla consists of Roche's trastuzumab antibody and ImmunoGen's DM1 cytotoxic agent. The DM1 is attached to the antibody using one of ImmunoGen's linkers. Roche has global development and commercialization rights for Kadcyla; ImmunoGen is entitled to receive specified milestone payments and royalties on product sales.