Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Capecitabine, Lapatinib in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with capecitabine for patients 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.