Innovation Janssen Research & Development, Los Angeles, U 11.



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SAN FRANCISCO, /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson will present today at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) early results from the ongoing Phase 2 GALAHAD study evaluating niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with metastatic castration-resistant … "GALAHAD is an ongoing open-label Phase 2 study assessing niraparib in patients with DRD who had progressed after treatment with next-generation androgen-receptor signaling therapies (ARSIs) and docetaxel.The most common Grade 3/4 adverse events (AEs) were primarily hematologic, which included anemia (26 percent), thrombocytopenia (15 percent), neutropenia (8 percent) and leukopenia (6 percent).“It is encouraging to see this promising response rate, since patients with this DNA-repair pathway defect typically only have an objective response rate of less than 15 percent and a median progression-free survival of three months with currently available therapies,” said Margaret Yu, M.D., Vice President, Clinical Development, Prostate, Janssen Research & Development, LLC. "These preliminary results suggest that PARP inhibition with niraparib may play an important role in the treatment of men with metastatic castration-resistant prostate cancer who have mutations in DNA-repair genes," said GALAHAD is an ongoing open-label Phase 2 study assessing niraparib in patients with DRD who had progressed after treatment with next-generation androgen-receptor signaling therapies (ARSIs) and docetaxel.The most common Grade 3/4 adverse events (AEs) were primarily hematologic, which included anemia (26 percent), thrombocytopenia (15 percent), neutropenia (8 percent) and leukopenia (6 percent). “Additional therapies are needed to address unmet medical needs in metastatic castration-resistant prostate cancer and we look forward to accumulating more evidence about the role of niraparib in this important setting. RARITAN, N.J.,October 3, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for niraparib, an orally-administered poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer …

All rights reserved. The site you’re being redirected to is a branded pharmaceutical website. You are now leaving jnj.com. Janssen Research & Development, Spring House, US 12. Janssen Announces Preliminary Results from Phase 2 GALAHAD Study in Adults with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Pathway Defects (DRD)Janssen Announces Preliminary Results from Phase 2 GALAHAD Study in Adults with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Pathway Defects (DRD) ... 10. In turn, the QUEST Phase 1/2 study (NCT03431350) tests Zejula combination therapies in patients with mCRPC. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. All Rights Reserved. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. GALAHAD is an ongoing open-label Phase II study assessing niraparib (300 mg daily) in patients with mCRPC and DNA repair defects with disease progression on taxane and androgen receptor-targeted therapy. Phase 2 study of niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD): preliminary results of GALAHAD. "It is encouraging to see this promising response rate, since patients with this DNA-repair pathway defect typically only have an objective response rate of less than 15 percent and a median progression-free survival of three months with currently available therapies," said We are Janssen. Al.

SAN FRANCISCO, Feb. 14, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson will present today at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) early results from the ongoing Phase 2 GALAHAD study evaluating niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with … "The GALAHAD study (NCT02854436), sponsored by Janssen, is testing 300 mg daily Zejula in patients whose disease worsened after treatment with next-generation androgen-receptor signaling therapies — a mainstay in the treatment of prostate cancer — and the chemotherapy docetaxel. Possible patient benefits: Eligible participants may receive all study‐required care at no charge. Learn more at SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson© 1985 - 2020 BioSpace.com. The MAGNITUDE study is a phase III look into the use of the drug with abiraterone acetate (Zytiga) and prednisone versus just abiraterone acetate and prednisone for the treatment of …
1 Smith, M. et. Galahad is a phase 2 clinical trial that will enroll approximately 215 participants. All contents © Copyright Johnson & Johnson Services, Inc.1997-2020. Powered by Madgex Job Board Software Johnson & Johnson: Janssen Announces Preliminary Results from Phase 2 GALAHAD Study in Adults with Metastatic Castration-Resistant Prostate Cancer … Learn more at SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson© 1985 - 2020 BioSpace.com.
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