"These positive decisions are important steps toward Kadcyla becoming available for patients in the EU and
The EMILIA trial assessed Kadcyla compared to standard therapy for the treatment of patients with HER2-positive metastatic breast cancer who had previously received Herceptin® (trastuzumab) and a taxane. Kadcyla demonstrated a significant improvement in overall survival and in progression-free survival, and fewer patients experienced severe adverse events, compared to standard therapy.
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.
Roche is conducting a number of studies assessing Kadcyla for potential additional uses. These include for the first-line treatment of HER2-positive metastatic breast cancer, for early stage HER2-positive breast cancer and for advanced HER2-positive gastric cancer. About
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