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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
FDA (1) ER positive, HER2-positive Invasive Breast Carcinoma Lapatinib, Letrozole
FDA (1) HER2-positive, PR positive Invasive Breast Carcinoma Lapatinib, Letrozole
FDA (1) ER positive, HER2-positive, PR positive Invasive Breast Carcinoma Lapatinib, Letrozole