Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Trastuzumab emtansine in patients with Invasive Breast Carcinoma.
The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab emtansine for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either (i) received prior therapy for locally advanced or metastatic disease or (ii) developed disease recurrence during or within six months of completing adjuvant therapy.
This statement is based on a regulatory approval from the Health Service Executive:
Treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: (i) Received prior therapy for locally advanced or metastatic disease, or (ii) Developed disease recurrence during or within six months of completing adjuvant therapy.