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.
This statement is based on a regulatory approval from the Health Service Executive:
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. Lynparza's product information fromcites 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.