Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that ER negative, HER2-negative, and PR negative status confers therapeutic sensitivity to Sacituzumab govitecan in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized sacituzumab govitecan as a monotherapy for the treatment of adult patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy.
This statement is based on a regulatory approval from the European Medicines Agency:
Trodelvy as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy.