Niraparib in the maintenance treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer: safety and efficacy

Abstract

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZEJULA safely and effectively. See full prescribing information for ZEJULA. ZEJULA TM (niraparib) capsules, for oral use Initial U.S. Approval: 2017 INDICATIONS AND USAGE ZEJULA is a poly(ADP-ribose) polymerase (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. (1) DOSAGE AND ADMINISTRATION  Recommended dose is 300 mg taken once daily with or without food. (2.1)  Continue treatment until disease progression or unacceptable adverse reaction. (2.1, 2.2)  For adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation. (2.2) DOSAGE FORMS AND STRENGTHS Capsules: 100 mg (3) CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS  Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML occurred in patients exposed to ZEJULA, and some cases were fatal. Monitor patients for hematological toxicity and discontinue if MDS/AML is confirmed (5.1)  Bone Marrow Suppression: Test complete blood counts weekly for the first month, monthly for the next 11 months and periodically thereafter for clinically significant changes. (5.2)  Cardiovascular Effects: Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Manage with antihypertensive medications as well as adjustment of the ZEJULA dose, if necessary. (5.3)  Embryo-Fetal Toxicity: ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.4, 8.1, 8.3) ADVERSE REACTIONS Most common adverse reactions (incidence ≥10%) are thrombocytopenia,

New insights for gynecological cancer therapies: from molecular mechanisms and clinical evidence to future directions

“…Among the 63 patients who had target lesions, the ORR for g BRCA m cohort was 33% and for non-g BRCA m cohort it was 4% [ 257 ]. Based on the QUADRA trial (NCT02354586), niraparib was approved in 2020 as the maintenance treatment for recurrent OC patients regardless of genetic profiles [ 258 ].…”