Zejula Granted FDA’s Breakthrough Therapy Status for Treating Metastatic Castration-resistant Prostate Cancer

Zejula Granted FDA’s Breakthrough Therapy Status for Treating Metastatic Castration-resistant Prostate Cancer
The oral ovarian cancer treatment Zejula (niraparib) has been given Breakthrough Therapy status by the U.S. Food and Drug Administration (FDA) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who carry BRCA mutations and have been previously treated with certain therapies, namely taxane chemotherapy and androgen-receptor targeted therapy. Breakthrough Therapy designation is expected to accelerate the development and regulatory review of an investigational treatment that's intended to treat a serious or life-threatening condition. The designation is given when preliminary evidence supports significant benefits of the new therapeutic candidate compared to available treatments. The FDA based its decision on a preliminary analysis of the ongoing GALAHAD study (NCT02854436), a Phase 2, open-label clinical trial running in multiple countries worldwide and sponsored by Janssen, a company owned by Johnson & Johnson
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