Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRCA2 pathogenic variants, HER2-negative status confers therapeutic sensitivity to Olaparib in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized olaparib as both a monotherapy and in combination with endocrine for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. Lynparza's product information cites the OlympiA trial, where olaparib was compared against placebo for the treatment of patients with germline BRCA1/2 mutated and HER2-negative high risk early breast cancer.
This statement is based on a regulatory approval from the European Medicines Agency:
Lynparza is indicated as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.