Niraparib Granted Breakthrough Therapy Designation in Metastatic Castration-Resistant Prostate Cancer
Posted: Friday, October 11, 2019
On October 3, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to the orally administered PARP inhibitor niraparib for the treatment of patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer who have received prior taxane chemotherapy and androgen receptor (AR)-targeted therapy.
The Breakthrough Therapy designation is based on data from the GALAHAD study (ClinicalTrials.gov identifier NCT02854436), a phase II, multicenter, open-label clinical trial evaluating the efficacy and safety of niraparib in the treatment of adult patients with metastatic castration-resistant prostate cancer and DNA-repair gene defects who had received treatment with next-generation AR-targeting therapies and docetaxel. Data from the GALAHAD study were recently presented at the European Society for Medical Oncology (ESMO) 2019 Annual Congress (Abstract LBA50).