Therapeutic Response

BRCA1 oncogenic variants status confers therapeutic sensitivity to Olaparib in patients with Ovarian Epithelial Tumor.

Statements

Source and description
Lynparza (olaparib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
Lynparza (olaparib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
Lynparza (olaparib) [product information]. EMA. The European Medicines Agency (EMA) has authorized olaparib as a monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Olaparib (Tablet) Monotherapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved olaparib (tablet) for reimbursement as a monotherapy treatment option for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube cancer, or primary peritoneal carcinoma who are in response (complete or partial) following first-line platinum-based chemotherapy.
Olaparib (Tablet) Monotherapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved olaparib (tablet) for reimbursement as a monotherapy treatment option for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.