Lynparza (oloparib) for maintenance in ovarian cancer – pro
Per the National Comprehensive Cancer Network Guidelines (NCCN) Version 3.2019, Olaparib is: “For patients with deleterious germline and/or somatic BRCA mutated (as detected by an FDA-approved test or other validated test performed in a CLIA-approved facility) advanced ovarian cancer who have been treated with two or more lines of chemotherapy.”
The U.S. Food and Drug Administration granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
“On December 19, 2018, the Food and Drug Administration approved olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Patients with gBRCAm advanced epithelial ovarian, fallopian tube or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic.”
According to Robson, M., et al, (2017), “Among patients with HER2-negative metastatic breast cancer and a germline BRCA mutation, olaparib monotherapy provided a significant benefit over standard therapy; median progression-free survival was 2.8 months longer and the risk of disease progression or death was 42% lower with olaparib monotherapy than with standard therapy.”
NCCN. (2019). Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Perioneal Cancer & Less Common Histopathologies.
Robson, M., et al. (2017). Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. doi: 10.1056/NEJMoa1706450.
United States Food and Drug Administration (USFDA). (2018). FDA approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based. Retrieved From: https://www.fda.gov/drugs/fda-approved-olaparib-lynparza-astrazeneca-pharmaceuticals-lp-maintenance-treatment-adult-patients