Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to lapatinib in combination with letrozole for the treatment of patients who are postmenopausal women with hormone receptor-positive metastatic breast cancers that overexpresses the HER2 receptor for whom hormonal therapy is indicated. Lapatinib's product label notes that lapatinib 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 as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER positive, HER2-positive	Invasive Breast Carcinoma	Lapatinib, Letrozole
Sensitivity (+)	HER2-positive, PR positive	Invasive Breast Carcinoma	Lapatinib, Letrozole
Sensitivity (+)	ER positive, HER2-positive, PR positive	Invasive Breast Carcinoma	Lapatinib, Letrozole