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NOVA Trial Dosing

For Recurrent Ovarian Cancer1

The approved starting dose of ZEJULA for recurrent ovarian cancer is 300 mg/day

ZEJULA Recommended Dose Modifications for Adverse Reactions1

Side Effects of ZEJULA May Be Managed With Dose Interruption and Modification1,2

In the NOVA trial, adverse reactions led to dose reduction or interruption in 69% of patients, most frequently from thrombocytopenia (41%) and anemia (20%). Discontinuation due to hematologic adverse reactions was uncommon for thrombocytopenia (3%), neutropenia (2%), and anemia (1%).

  • The incidence of grade 3/4 thrombocytopenia by dose at onset was 2.3%, 5.9%, and 33.2% for patients receiving  ZEJULA doses of 100 mg,  200 mg, and 300 mg, respectively2

An Exploratory Subgroup Analysis in NOVA Suggested Efficacy Was Not Compromised by Dose Reduction3

The analysis is exploratory in nature; it does not control for type 1 error and is not powered to determine treatment effect in any subgroup.

  • Interrupt and reduce dose at the first sign of unacceptable toxicity1

In a post hoc analysis, the estimated PFS probability by dose level was measured after cycle 3 for patients regardless of BRCA status (ie, time 0 = month 3 of treatment). Patients who began  ZEJULA at 300 mg and were titrated to their individual maximum tolerated dose achieved a similar PFS benefit regardless of the final dose level.4

Censored subjects are indicated by circles.

The Side Effect Profile of ZEJULA Is Well Characterized1

  • No on-treatment deaths were reported during the trial5

ALT, alanine aminotransferase; AST, aspartate aminotransferase; BRCA, breast cancer susceptibility gene; BRCA−, not BRCA-mutated; PFS, progression-free survival.

Efficacy data

EFFICACY DATA

View efficacy data for all indications

See the Data

References: 1. ZEJULA (niraparib). Prescribing Information. GlaxoSmithKline; 2020. 2. Berek JS, Matulonis UA, Peen U, et al. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018;29(8):1784-1792 [RADAR]. 3. Wang J, Zhang Z-Y, Mirza MR, et al. The exposure-response relationship of niraparib in patients with gBRCAmut and non-gBRCAmut: results from the ENGOT-OV16/NOVA trial. Poster presented at: Annual Congress of the European Society for Medical Oncology; September 8-12, 2017; Madrid, Spain. 4. Data on file, GlaxoSmithKline. 5. Mirza MR, Monk BJ, Herrstedt J, et al; for the ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer [supplementary index]. N Engl J Med. 2016;375(22):2154-2164.