Niraparib is an orally-administered selective PARP inhibitor that is currently being studied by Janssen for the treatment of patients with prostate cancer.
Forty-two percent of patients had at least 1 serious AE.AEs leading to discontinuation, including anemia in 7 patients and thrombocytopenia in 6, were reported in 20% of patients. The most common grade 3/4 AEs included anemia in 29% and thrombocytopenia in 15%, but overall grade 3/4 events were mostly hematologic and could be managed with dose interruption or modification. Innovation The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Niraparib, an orally-administered poly ADP-ribose polymerase (PARP) inhibitor. Reviewed by Judith Stewart BPharm.Last updated on Apr 30, 2020. All Rights Reserved. Prior PARP inhibition or platinum-based chemotherapy was not allowed.Objective response rate (ORR) by RECIST 1.1 criteria with no evidence of bone progression by Prostate Cancer Working Group 3 criteria in patients with biallelicAs of the data cutoff, 223 patients were screened and 165 of these patients were enrolled. All contents © Copyright Johnson & Johnson Services, Inc.1997-2020. AEs led to death in 9 total patients, due to general deterioration in 3; cardiac failure in 2; anemia, hypocalcemia, hematuria in 1 patient each; and urosepsis, seizure, and acute respiratory failure in 1 patient each.Niraparib is approved by the FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a CR or PR to platinum-based chemotherapy. Follow us at www.twitter.com/JanssenGlobal. The FDA has granted a breakthrough therapy designation to niraparib (Zejula) for the treatment of patients with“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, said in a press release. Eighty-one patients (49.1%) had biallelic DRD, including 46 who hadOf the patients with biallelic DRD, the mean age was 68.2 years and about half of the patients (53%) had an ECOG performance status of 1 and a Gleason score ≥8 (64%). Prior AR-targeted therapy consisted of abiraterone acetate (Zytiga) and prednisone in 67% and enzalutamide (Xtandi) in 65%. Issued: London, UK. “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.”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.This site is governed solely by applicable U.S. laws and governmental regulations. Johnson & Johnson’s Janssen Biotech will develop TESARO’s Phase III prostate cancer treatment niraparib worldwide except Japan under an up-to-$450 million collaboration. Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Niraparib for the Treatment of Metastatic Castration-Resistant Prostate CancerJanssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Niraparib for the Treatment of Metastatic Castration-Resistant Prostate Cancer