Therapeutic Response

HER2-positive status confers therapeutic sensitivity to Capecitabine in combination with Lapatinib in patients with Invasive Breast Carcinoma.

Statements

Source and description
Tyverb (lapatinib) [product information]. EMA.

The European Medicines Agency (EMA) has authorized laplatinib in combination with capecitabine for the treatment of adult patients with breast cancer, whose tumors overexpress HER2 (ErbB2), with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting. Lapatinib's product information sheet further defines HER2 (ErbB2) overexpressing tumors as IHC3+, or IHC2+ with gene amplification or gene amplification alone.
Tykerb (lapatinib) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, a trastuzumab.
Lapatinib and Capecitabine Therapy. NCCP National SACT Regimen. HSE.

The Republic of Ireland's Health Service Executive (HSE) has approved lapatinib in combination with capecitabine for reimbursement as a treatment option for the treatment of adult patients with advanced or metastatic breast cancer whose tumors overexpress HER2 with disease progression following prior therapy, which should have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.