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# Breakthrough Status for Janssen’s Niraparib
- URL: https://www.fdaweb.com/breakthrough-status-for-janssens-niraparib/
- Published: 2019-10-04T12:00:00.000Z
- Updated: 2026-09-15T01:54:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145174

FDA has granted Janssen Pharmaceutical a breakthrough therapy designation for niraparib, an orally-administered poly ADP-ribose polymerase inhibitor, for treating patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer who have received prior taxane chemotherapy and androgen receptor-targeted therapy. The designation is based on data from the GALAHAD study, a Phase 2, multicenter, open-label clinical trial. Preliminary data showed that about 40% of patients demonstrated an objective response, defined by the Response Evaluation Criteria in Solid Tumors guideline, the company says.