Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER negative, HER2-negative, PR negative status confers therapeutic sensitivity to Sacituzumab govitecan in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized sacituzumab govitecan for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease.
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 unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease.