October 04, 2019
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FDA grants breakthrough therapy designation to Zejula for prostate cancer subtype

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The FDA granted niraparib breakthrough therapy designation for the treatment of men with BRCA1/BRCA2-mutated metastatic castration-resistant prostate cancer who received prior taxane chemotherapy and androgen receptor-targeted therapy, according to a press release from the agent’s manufacturer.

Niraparib (Zejula; Janssen, Tesaro) is an orally administered poly(ADP-ribose) polymerase (PARP) inhibitor.

The FDA based the breakthrough therapy designation, in part, on data from the phase 2, multicenter, open-label GALAHAD study, which is evaluating the safety and efficacy of niraparib for men with metastatic castration-resistant prostate cancer and DNA-repair gene defects, of which BRCA1/BRCA2 are the most common. Patients with these specific gene defects are at increased risk for prostate cancer and high-risk disease.

All men in the trial had previously received treatment with a next-generation androgen-receptor targeting therapy and docetaxel.

Results of a prespecified interim analysis of the study — presented at this year’s European Society of Medical Oncology Congress — showed niraparib induced clinical activity among men with treatment-refractory metastatic castration-resistant prostate cancer. Researchers noted durable responses particularly in biallelic BRCA mutation carriers.

“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 of clinical development, solid tumors at Janssen Research & Development LLC, said in the 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.”