A new orally-administered poly ADP-ribose polymerase (PARP) inhibitor, Niraparib has been launched by the Janssen Pharmaceutical Companies of Johnson & Johnson.
The PARP inhibitor is used to treat patients with BRCA 1/2 gene-mutated metastatic castration-resistant prostate cancer (mCRPC) and DNA repair gene defects (DRD). The BRCA 1/2 mutations are the most common 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.
Niraparib is intended for patients who have previously received taxane chemotherapy and androgen receptor (AR)-targeted therapy.
Metastatic castration-resistant prostate cancer is a form of prostate cancer that has spread to other parts of the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels.
The most common metastatic sites are bones, followed by distant lymph nodes, liver, and the thorax. The second most common type of cancer in men worldwide is prostate cancer. Almost, one million people are diagnosed with prostate cancer every year.
Currently, Niraparib is being investigated in a Phase III trial in combination with ZYTIGA® (abiraterone acetate) and prednisone in adults with metastatic prostate cancer.
The Breakthrough Designation granted by the US Food and Drug Administration is based on findings from the GALAHAD study, a phase 2, multicenter, open-label clinical trial evaluating the safety and efficacy of Niraparib in the treatment of adult patients with mCRPC and DRD who were treated with next-generation androgen-receptor targeting therapies and docetaxel.