Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-positive status confers therapeutic sensitivity to Lapatinib, Letrozole in patients with Invasive Breast Carcinoma.
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 statement is based on a regulatory approval from the Food and Drug Administration:
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.