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Janssen’s niraparib received breakthrough designation for metastatic castration-prostate cancer

Updated: Oct 6, 2019

Janssen's niraparib, an orally-administered poly ADP-ribose polymerase (PARP) inhibitor received breakthrough designation from the US FDA. The drug is indicated in patients suffering from BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer (mCRPC); who were previously treated with taxane chemotherapy and androgen receptor (AR)-targeted therapy.


The approval was based on GALAHAD study, a Phase 2, multicenter, open-label clinical trial.


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BRCA1/2 mutations are the most common DNA-gene defects. The primary endpoint was the objective response rate. The study included 46 patients with BRCA mutation and 35 patients with non-BRCA mutated mCRPC. Overall response rate was 41%, CRR was 63% in BRCA mutated patients. Objective response rate was 5.5 months. In non-BRCA patients, CRR was 17%, objective response was reported in two patients and the duration was 3.8 and 6.5 months.


The results were reported in ESMO2019.


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