also considered for EC
"Kadcyla has been approved for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin(R) (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.
As with the Kadcyla approvals that have been granted in the US, Japan, and other geographies, the approval in the EU is based on the findings in the EMILIA Phase III trial. In the EU and other international markets, the timing of the commercial availability of Kadcyla after approval can vary due to national differences in processes for establishing pricing/reimbursement, with some countries - including Germany - able to launch shortly after approval."