Niraparib

Phase 3 PRIMA trial of Zejula® (niraparib) is the first study to show a PARP inhibitor significantly improves PFS, regardless of biomarker status, when given as monotherapy in women with first-line platinum responsive advanced ovarian cancer

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Sunday, September 29, 2019
PARP inhibitors, Clinical research, Niraparib, Clinical trials, Design of experiments, Placebo-controlled study

PRIMA is a double-blind, randomized, placebo-controlled Phase 3 study of Zejula (niraparib) as a maintenance therapy in women with first-line ovarian cancer following a response to platinum-based chemotherapy.

Key Points: 
  • PRIMA is a double-blind, randomized, placebo-controlled Phase 3 study of Zejula (niraparib) as a maintenance therapy in women with first-line ovarian cancer following a response to platinum-based chemotherapy.
  • In an interim analysis of overall survival (OS), niraparib also demonstrated an encouraging trend toward improvement in OS relative to placebo.
  • A pre-planned interim analysis of OS numerically favored niraparib in the overall population (HR 0.70; 95% CI 0.44-1.11).
  • PRIMA is a double-blind, randomized Phase 3 study designed to evaluate niraparib versus placebo in first-line Stage III or IV ovarian cancer patients.

Janssen to Highlight Depth of Solid Tumour Portfolio with Multiple Data Presentations at ESMO 2019

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Wednesday, September 18, 2019
Oncology, Health, Clinical trials, Pharmaceutical, Biotechnology, SEC filings, Companies, Tesaro, Johnson & Johnson, Form 10-Q, Niraparib, Janssen Pharmaceutica, Janssen, Economy of the United States, ERLEADA® (apalutamide), ZYTIGA® (abiraterone acetate), BALVERSATM (erdafitinib), niraparib

Risk Factors, and in the companys most recently filed Quarterly Report on Form 10-Q, and the companys subsequent filings with the Securities and Exchange Commission.

Key Points: 
  • Risk Factors, and in the companys most recently filed Quarterly Report on Form 10-Q, and the companys subsequent filings with the Securities and Exchange Commission.
  • Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson.
  • None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
  • Janssen Enters Worldwide Collaboration and License Agreement with TESARO, Inc., for Niraparib in Prostate Cancer.

Janssen to Highlight Depth of Prostate Cancer and Solid Tumor Portfolios with Multiple Data Presentations at ESMO 2019

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Tuesday, September 17, 2019
Companies, PARP inhibitors, Niraparib, Economy of the United States, Life sciences, Johnson & Johnson, Janssen Pharmaceutica, Tesaro, PARP, Janssen Biotech, Poly (ADP-ribose) polymerase, Janssen

Niraparib is an orally-administered selective poly ADP ribose polymerase (PARP) inhibitor that is currently being studied by Janssen for the treatment of patients with prostate cancer.

Key Points: 
  • Niraparib is an orally-administered selective poly ADP ribose polymerase (PARP) inhibitor that is currently being studied by Janssen for the treatment of patients with prostate cancer.
  • In April 2016, Janssen entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc., for exclusive rights to niraparib in prostate cancer.
  • This indication was approved by the U.S. FDA on April 12, 2019 under an accelerated approval based on tumor response rate.
  • Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Zai Lab Announces Publication of Pharmacokinetic Study of Niraparib in Chinese Ovarian Cancer Patients

Retrieved on: 
Tuesday, August 27, 2019
Gynaecology, Human female reproductive system, Pelvis, PARP inhibitors, Health, Niraparib, Cancer, Medical specialties, Gynaecological cancer, Ovarian cancer, Primary peritoneal carcinoma, Fallopian tube

SHANGHAI, China, and SAN FRANCISCO, Aug. 27, 2019 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, today announced publication of the open-label study evaluating the pharmacokinetic (PK) profile of niraparib in Chinese ovarian cancer patients.

Key Points: 
  • SHANGHAI, China, and SAN FRANCISCO, Aug. 27, 2019 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, today announced publication of the open-label study evaluating the pharmacokinetic (PK) profile of niraparib in Chinese ovarian cancer patients.
  • Results from the study show a PK profile of niraparib in Chinese patients comparable to that of patients evaluated in GSKs global PK study.The study was published online in The Oncologist (DOI: 10.1634/theoncologist.2019-0565).
  • The open-label PK study enrolled 36 Chinese patients with stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer.
  • The primary objective of the study was to assess the PK profile of niraparib in Chinese patients following both single and multiple doses.