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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.

Citation:

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.