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FDA Grants Niraparib Breakthrough Designation for BRCA+ mCRPC

Gina Columbus @ginacolumbusonc
Published: Thursday, Oct 03, 2019

The FDA has granted a breakthrough therapy designation to the PARP inhibitor niraparib (Zejula) for the treatment of patients with BRCA1/2–mutant metastatic castration-resistant prostate cancer (mCRPC) who have previously received taxane-based chemotherapy and an androgen receptor (AR) inhibitor.

The decision is based on findings from the phase II GALAHAD study (NCT02854436), in which niraparib demonstrated a 41% objective response rate (ORR) in patients with mCRPC who have BRCA biallelic DNA-repair gene defects (DRD). The prespecified interim analysis of the trial was recently presented at the 2019 ESMO Congress.

"Niraparib is a PARP inhibitor that we believe may help address an important unmet need for patients with metastatic castration-resistant prostate cancer who have mutations in DNA-repair genes," Kiran Patel, MD, vice president, clinical development, solid tumors, Janssen Research & Development, LLC, the developer of niraparib, stated in a press release. "We are pleased with the FDA's Breakthrough Therapy Designation as we continue the clinical development of niraparib, and we look forward to working with the agency in our continued focus and commitment to bring new advancements to patients diagnosed with prostate cancer."

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