Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, ERBB2 amplification, PR negative status confers therapeutic sensitivity to Lapatinib, Trastuzumab in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized laplatinib in combination with trastuzumab for the treatment of adult patients with breast cancer, whose tumors overexpress HER2 (ErbB2), with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy in combination with chemotherapy. 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 trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy.