FDA Grants Priority Review for Olaparib in Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for a supplemental New Drug Application for the use of olaparib (Lynparza) in patients with germline BRCA-mutated HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, as announced on October 18, 2017, by AstraZeneca and Merck & Co.
The supplemental New Drug Application is based on the results of the randomized phase III OlympiAD trial, published in the The New England Journal of Medicine. A total of 302 patients from nearly 20 countries were included in the OlympiAD trial, where researchers assessed the efficacy and safety of olaparib tablets compared with standard-of-care chemotherapy. Median progression-free survival was significantly longer in the olaparib group than in the standard-therapy group (7.0 vs 4.2 months), with a response rate of 59.9% in the olaparib group and 28.8% in the standard-therapy group.
Olaparib has been used to treat more than 3000 patients with advanced ovarian cancer and is currently being tested in other tumor types, including breast, prostate, and colorectal cancers.