Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized trastuzumab emtansine 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. The product information further specifies that patients treated with trastuzumab emtansine should have HER2 positive tumor status, defined as a score of 3+ by immunohistochemistry (IHC) or a ratio of >= 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a CE-marked In Vitro Diagnostic (IVD) medical device. If a CE-marked IVD is not available, the HER2-status should be assessed by an alternate validated test.

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	HER2-positive	Invasive Breast Carcinoma	Trastuzumab emtansine

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2019-12-16	European Medicines Agency	Indication received approval from the European Commission.