PT  - JOURNAL ARTICLE
AU  - Ison, Gwynn
AU  - Howie, Lynn J.
AU  - Amiri-Kordestani, Laleh
AU  - Zhang, Lijun
AU  - Tang, Shenghui
AU  - Sridhara, Rajeshwari
AU  - Pierre, Vadryn
AU  - Charlab, Rosane
AU  - Ramamoorthy, Anuradha
AU  - Song, Pengfei
AU  - Li, Fang
AU  - Yu, Jingyu
AU  - Manheng, Wimolnut
AU  - Palmby, Todd R.
AU  - Ghosh, Soma
AU  - Horne, Hisani N.
AU  - Lee, Eunice Y.
AU  - Philip, Reena
AU  - Dave, Kaushalkumar
AU  - Chen, Xiao Hong
AU  - Kelly, Sharon L.
AU  - Janoria, Kumar G.
AU  - Banerjee, Anamitro
AU  - Eradiri, Okponanabofa
AU  - Dinin, Jeannette
AU  - Goldberg, Kirsten B.
AU  - Pierce, William F.
AU  - Ibrahim, Amna
AU  - Kluetz, Paul G.
AU  - Blumenthal, Gideon M.
AU  - Beaver, Julia A.
AU  - Pazdur, Richard
TI  - FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
AID  - 10.1158/1078-0432.CCR-18-0042
DP  - 2018 Sep 01
TA  - Clinical Cancer Research
PG  - 4066--4071
VI  - 24
IP  - 17
4099  - http://clincancerres.aacrjournals.org/content/24/17/4066.short
4100  - http://clincancerres.aacrjournals.org/content/24/17/4066.full
SO  - Clin Cancer Res2018 Sep 01; 24
AB  - The FDA approved niraparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, on March 27, 2017, for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy. Approval was based on data from the NOVA trial comparing niraparib with placebo in two independent cohorts, based on germline BRCA mutation status (gBRCAm vs. non-gBRCAm). Progression-free survival (PFS) in each cohort was the primary endpoint. In the gBRCAm cohort, estimated median PFS on niraparib was 21 months versus 5.5 months on placebo [HR, 0.26; 95% confidence interval (CI), 0.17–0.41; P < 0.0001]. In the non-gBRCAm cohort, estimated median PFS for niraparib and placebo was 9.3 and 3.9 months, respectively (HR, 0.45; 95% CI, 0.34–0.61; P < 0.0001). Common adverse reactions (>20% and higher incidence in the niraparib arm) with niraparib included thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, mucositis, fatigue, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash, and hypertension. There were five cases of myelodysplastic syndrome and acute myeloid leukemia (1.4%) in patients treated with niraparib compared with two cases (1.1%) on placebo. Niraparib is the first PARP inhibitor approved as maintenance therapy for patients with ovarian, fallopian tube, or primary peritoneal cancer, with improvement in PFS, regardless of gBRCAm status. Clin Cancer Res; 24(17); 4066–71. ©2018 AACR.See related commentary by Konstantinopoulos and Matulonis, p. 4062