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 a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered sunsuitable for endocrine therapy.
This statement is based on a regulatory approval from the European Medicines Agency:
Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.