'Breakthrough' status for niraparib in mCRPC

The US Food and Drug Administration 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 (AR)-targeted therapy.

The niraparib designation was granted to Johnson & Johnson (NYSE: JNJ) subsidiary Janssen, which acquired exclusive rights to the drug in the prostate cancer indication in 2016 from Tesaro. It is also marketed by GlaxoSmithKline (LSE: GSK), which acquired Tesaro, under the trade name Zejula for the treatment of ovarian, fallopian and primary peritoneal cancer.

BRCA1/2 mutations are the most common DNA-repair gene defects (DRD) in patients with mCRPC. Patients with a DRD in BRCA1/2 are at an elevated risk for both prostate cancer occurrence and more aggressive disease.