Posted by Michael Wonder on 04 Oct 2019
Janssen announces U.S. FDA breakthrough therapy designation granted for niraparib for the treatment of metastatic castration-resistant prostate cancer
3 October 2019 - Niraparib, an orally-administered PARP inhibitor, is currently being investigated for the treatment of patients with metastatic castration-resistant prostate cancer and BRCA1/2 DNA repair gene defects.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. FDA has granted breakthrough therapy designation for niraparib, an orally-administered poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have received prior taxane chemotherapy and androgen receptor-targeted therapy.
The breakthrough therapy designation is based on data from the GALAHAD study, a Phase 2, multi-center, open-label clinical trial evaluating the efficacy and safety of niraparib in the treatment of adult patients with mCRPC and DRD who had received treatment with next-generation androgen-receptor targeting therapies and docetaxel.
