Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that HER2-positive status confers therapeutic sensitivity to Trastuzumab emtansine in patients with Invasive Breast Carcinoma.

The U.S. Food and Drug Administration granted approval to ado-trastuzumab emtansine for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for ado-trastuzumab emtansine.

This statement is based on a regulatory approval from the Food and Drug Administration:

KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA.

Citation

Genentech, Inc. Kadcyla (ado-trastuzumab emtansine) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf. Revised January 2022. Accessed October 30, 2024. Genentech, Inc. Kadcyla (ado-trastuzumab emtansine) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125427s105lbl.pdf. Revised May 2019. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2019-05-03	Food and Drug Administration	Indication received traditional approval.