Trastuzumab emtansine
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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