FDA Grants Expanded Approval to Olaparib for BRCA-Mutant Metastatic Breast Cancer
Posted: Friday, January 12, 2018
Today, the U.S. Food and Drug Administration (FDA) expanded the approved use of olaparib (Lynparza) tablets to include the treatment of patients with metastasized breast cancer with a BRCA mutation. This approval makes olaparib the first poly ADP-ribose polymerase (PARP) inhibitor approved to treat breast cancer, and it is the first time any drug has been approved to treat patients with metastatic BRCA-mutant breast cancer. The FDA also expanded the approval of the BRCAnalysis CDx, an approved companion diagnostic to olaparib, to include the detection of BRCA mutations in blood samples from patients with breast cancer.
The safety and efficacy of olaparib for the treatment of breast cancer are based on a randomized clinical trial of 302 patients with HER2-negative metastatic breast cancer with a germline BRCA mutation. The median progression-free survival with olaparib was 7 months compared with 4.2 months with chemotherapy alone.
The most common adverse events associated with olaparib include anemia, neutropenia, leukopenia, nausea, fatigue, and vomiting.
Olaparib is also approved for the treatment of patients with BRCA-mutated, advanced ovarian cancer who have received three or more treatments of chemotherapy and for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors have completely or partially responded to chemotherapy.