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Zejula Approval History

Reviewed on Mar 27, 2017 by J.Stewart BPharm

Zejula (niraparib) is an oral, poly ADP-ribose polymerase (PARP) inhibitor for the maintenance treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

The FDA approval of Zejula was based on results of the NOVA trial, a double-blind, placebo-controlled Phase 3 study of 553 patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who were in a complete or partial response to their most recent platinum-based chemotherapy. Patients were assigned into cohorts dependent on their germline BRCA mutation status. Those with the germline BRCA mutation who received Zejula had a median progression-free survival (time the tumors did not grow after treatment) of 21 months, compared to 5.5 months in those taking the placebo. Patients without the germline BRCA mutation had a median progression-free survival of 9.3 months compared to 3.9 months in those taking the placebo.

Zejula is administered as oral capsules taken once daily at the same time each day. Common side effects include thrombocytopenia, anemia, neutropenia, leukopenia, palpitations, nausea, constipation, vomiting, abdominal pain/distention, mucositis/stomatitis, diarrhea, dyspepsia, dry mouth, fatigue/asthenia, decreased appetite, urinary tract infection, AST/ALT elevation, myalgia, back pain, arthralgia, headache, dizziness, dysgeusia, insomnia, anxiety, nasopharyngitis, dyspnea, cough, rash, and hypertension.

Development History and FDA Approval Process for Zejula

Mar 27, 2017Approval Tesaro Announces FDA Approval of Zejula (niraparib) for Women with Recurrent Ovarian Cancer
Dec 20, 2016Tesaro Announces Priority Review Designation for Niraparib NDA
Nov  1, 2016Tesaro Announces Submission of Niraparib NDA For Platinum-sensitive, Recurrent Ovarian Cancer
Sep 12, 2016Tesaro Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission
Jun 29, 2016Tesaro's Niraparib Significantly Improved Progression-Free Survival for Patients With Ovarian Cancer in Both Cohorts of the Phase 3 NOVA Trial
Jun  4, 2013Tesaro and the European Network of Gynecological Oncological Trial Groups Forge Partnership to Develop Niraparib for Ovarian Cancer
Jun  4, 2013TESARO Details Niraparib Phase 1 Clinical Data Presented at the 2013 ASCO Annual Meeting

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