Trastuzumab emtansine

Trastuzumab emtansine (Kadcyla, Roche Registration GmbH) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: HER2 (2).
Approved indications of Trastuzumab emtansine
Biomarker requirementRegimenSettingConditions
Breast cancer2
HER2 IHC 3+ or IHC 2+/ISH-positive
Monotherapy
Adj.
early
After neoadjuvant taxane-based and HER2-targeted therapy; Residual invasive disease, in the breast and/or lymph nodes
HER2 IHC 3+ or IHC 2+/ISH-positive
Monotherapy
2L
advanced
After prior trastuzumab and a taxane, separately or in combination; and either prior therapy for locally advanced or metastatic disease, or disease recurrence during or within six months of completing adjuvant therapy
Full text of section 4.1 (therapeutic indications)

Early Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Metastatic Breast Cancer (MBC) 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.

Label history

20 changes to the Kadcyla label since 2015, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes