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Niraparib’s safety was evaluated in 367 patients with platinum-sensitive recurrent ovarian, fallopian tube, and primary peritoneal cancer in the NOVA trial. FDA approved this application approximately three months ahead of the goal date. QUADRA was a multicentre, open-label, single-arm, phase 2 study that evaluated the safety and activity of niraparib in adult patients (≥18 years) with relapsed, high-grade serous (grade 2 or 3) epithelial ovarian, fallopian tube, or primary peritoneal cancer who had been treated with three or more previous chemotherapy regimens. On October 23, 2019,the Food and Drug Administration approved niraparib (ZEJULA, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. Methods: Eligible pts had grade 2 or 3 serous ROC, ≥3 … Methods QUADRA was a multicentre, open-label, single-arm, phase 2 study that evaluated the safety and activity of niraparib in adult patients (≥18 years) with relapsed, high-grade serous (grade 2 or 3) epithelial ovarian, fallopian tube, or primary peritoneal cancer who had been treated with three or more previous chemotherapy regimens. In QUADRA, serious adverse reactions occurred in 43% of patients receiving ZEJULA. A description of FDA expedited programs is in the Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Patients should be selected for therapy based on an FDA-approved companion diagnostic for niraparib.The FDA also approved the Myriad myChoice CDx test for determination of tumor HRD status to select patients for niraparib.FDA granted this application priority review. In the multicenter, open-label, single-arm, QUADRA study, researchers evaluated the safety and efficacy of niraparib in 463 adult patients with metastatic, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who previously received ≥3 lines of chemotherapy. In QUADRA, less than 20% of patients had a BRCA mutation, 27% received niraparib as a sixth or later line therapy, two-thirds were platinum resistant or … All were partial responses. In this study (QUADRA), we investigated the activity of niraparib monotherapy as the fourth or later line of therapy. The objective of this study was to determine the cost effectiveness of niraparib maintenance therapy in patients with newly diagnosed ovarian cancer. However, rates of most common adverse reactions observed in QUADRA were different from NOVA, and fatal adverse reactions occurred in 2% of patients, including cardiac arrest. 00053). A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at

Listing a study does not mean it has been evaluated by the U.S. Federal Government. Patients were treated with three or more prior lines of chemotherapy. The most common adverse reactions (The recommended niraparib dose is 300 mg taken once daily with or without food. On March 27, 2017 , the U.S. Food and Drug Administration approved niraparib (ZEJULA, Tesaro, Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.Approval was based on a randomized trial (NOVA) of 553 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received at least two prior treatments of platinum-based chemotherapy and were in a complete or partial response to the most recent chemotherapy treatment.

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