Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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
2013-11-15	European Medicines Agency	Indication received approval from the European Commission.