J&J’s Janssen gets breakthrough status for niraparib in prostate cancer

The U.S. Food and Drug Administrations grants Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutical unit a breakthrough therapy designation for niraparib, an orally administered PARP inhibitor for the treatment of patients with a certain type of prostate cancer and who have already been treated with taxane chemotherapy and androgen receptor-targeted therapy.

JNJ gains 1.0% in after-hours trading.

The poly ADP-ribose polymerase inhibitor is being studied to treat patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer. BRCA1/2 mutations are the most common DNA-repair gene defects (DRD) in patients with mCRPC.

The designation is based on data from the Galahad study, a Phase 2, multicenter, 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.

https://seekingalpha.com/news/3503876-j-and-js-janssen-gets-breakthrough-designation-niraparib-prostate-cancer