Tykerb (lapatinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
TYKERB is a kinase inhibitor indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use: Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.	1
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.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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