Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 28 March 2018

Indication(s)

Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:
- Received prior therapy for locally advanced or metastatic disease, or
- Developed disease recurrence during or within six months of completing adjuvant therapy.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/002389
Orphan designation No
Date First Approved 15-11-2013
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Roche Registration Ltd
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions