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FDA Approves Zejula for Recurrent Ovarian Cancer
Tesaro news release; 2017 Mar 27
The FDA has approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Indications: Zejula is an ADP-ribose PARP inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Dosage and administration: Recommended dose is 300 mg taken once daily.
Efficacy and safety: Approval is based on results from a first-line phase 3 trial demonstrating that participants with and without germline BRCA mutations taking Zejula experienced increased progression-free survival vs those in a control group.
Side effects/risks: The most common adverse reactions are 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.
Tesaro announces U.S. FDA approval of Zejula (niraparib) for women with recurrent ovarian cancer. [news release]. Waltham, MA: Tesaro, Inc March 27, 2017. http://files.shareholder.com/downloads/AMDA-Z6KN1/4164210600x0x934849/52B39B23-4A61-475B-955F-2F9C99645F81/Zejula_FDA_approval_news_release_032417.pdf. Accessed March 31, 2017.
Zejula [package insert]. Waltham, MA: Tesaro Inc. 2017. http://zejula.com/docs/Zejula_(niraparib)_Full_Prescribing_Information.pdf. Accessed March 31, 2017.