Regulatory approval

Published by the Food and Drug Administration. Approved

TYKERB is a kinase inhibitor indicated in combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.

This is written in the approval document.

Citation

Novartis Pharmaceuticals Corporation. Tykerb (lapatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022059s031lbl.pdf. Revised March 2022. Accessed October 30, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-positive	Invasive Breast Carcinoma	Lapatinib, Letrozole
FDA (2)	HER2-positive, PR positive	Invasive Breast Carcinoma	Lapatinib, Letrozole
FDA (2)	ER positive, HER2-positive, PR positive	Invasive Breast Carcinoma	Lapatinib, Letrozole

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2010-01-29	Food and Drug Administration	Indication received traditional approval.