Kadcyla (trastuzumab emtansine) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Roche Registration GmbH. Kadcyla (trastuzumab emtansine) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf. Revised March 2023. Accessed March 19, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Trastuzumab emtansine
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Trastuzumab emtansine
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Trastuzumab emtansine
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Trastuzumab emtansine