Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER negative, HER2-negative, PR negative status confers therapeutic sensitivity to Pembrolizumab in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized pembrolizumab in combination with chemotherapy for the neoadjuvant treatment, and then continued as a monotherapy for the adjuvant treatment after surgery, of adult patients with locally advanced or early-stage triple-negative breast cancer at high risk of recurrence.
This statement is based on a regulatory approval from the European Medicines Agency:
KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence.