By clicking "I agree" you consent to the use of cookies for non-essential functions and the related processing of personal data. Please click below to continue to that site. You can adjust your cookie and associated data processing preferences at any time via our "Cookie Settings". The Breakthrough Therapy Designation is based on data from the GALAHAD study, a Phase 2, multicenter, open-label clinical trial evaluating the efficacy and safety of niraparib in the treatment of adult patients with mCRPC and DRD who had received treatment with next-generation androgen-receptor targeting therapies and docetaxel.

You can adjust the available sliders to ‘Enabled’ or ‘Disabled’, then click ‘Save and Accept’. The Breakthrough Therapy Designation is based on data from the GALAHAD study, a Phase 2, multicenter, open-label clinical trial evaluating the efficacy and safety of niraparib in the treatment of adult patients with mCRPC and DRD who had received treatment with next-generation androgen-receptor targeting therapies and docetaxel. Pre-specified interim analysis of GALAHAD: a phase 2 study of niraparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD). The Breakthrough Therapy designation for Lynparza in this patient population means the FDA will expedite review of submission data within 60 days of receipt. Advancing New Healthcare Solutions Through CollaborationLearn About the Company's Rich Heritage at Our Digital Museum Innovation Presented at: 2019 ESMO Congress; September 27-October 1, 2019; Barcelona, Spain. Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca, said: “More than 27,000 men died of prostate cancer last year in the US alone.

“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,” said Kiran Patel, MD, vice president, clinical development, solid tumors, at Janssen Research and Development, LLC. The QUEST trial is also underway, a phase Ib/II look into niraparib combination therapies.Smith MR, Sandhu S, Kelly WK, et al. The FDA has granted a breakthrough therapy designation to niraparib (Zejula) for the treatment of men with BRCA1/2 -mutant positive metastatic castration-resistant prostate cancer (mCRPC) who have previously received taxane-based chemotherapy and an androgen receptor (AR) inhibitor, according to Janssen, the drug’s developer. All Rights Reserved. This site is governed solely by applicable U.S. laws and governmental regulations. Please see our BRCA1/2 mutations are the most common DNA-repair gene defects (DRD) in patients with mCRPC.“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,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “…we look forward to working with (the FDA) in our continued focus and commitment to bring new advancements to patients diagnosed with prostate cancer.”Janssen also has other ongoing studies for niraparib in treating prostate cancer. View our Necessary cookies are absolutely essential for the website to function properly. For our other types of cookies “Advertising & Targeting”, “Analytics” and “Performance”, these help us analyse and understand how you use this website.

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