Zejula Approval History
- FDA approved: Yes (First approved March 27th, 2017)
- Brand name: Zejula
- Generic name: niraparib
- Dosage form: Capsules
- Company: Tesaro Inc.
- Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
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
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