ing ZEJULA and 69% of patients receiving placebo had an ECOG of 0 at study baseline. Approximately 40% of patients were enrolled in the U.S. or Canada and 51% of all patients were in complete response to most recent platinum-based regimen, with 39% on both arms with an interval of 6-12 months since the penultimate platinum regimen. Twenty-six percent of those treated with ZEJULA and 31% treated with placebo had received prior bevacizumab therapy. Approximately 40% of patients had 3 or more lines of treatment.
The trial demonstrated a statistically significant improvement in PFS for patients randomized to ZEJULA as compared with placebo in the gBRCAmut cohort and the non-gBRCAmut cohort (Table 6, and Figures 1 and 2).
Table 6: Efficacy Results - Study 1 (IRC Assessment*, Intent-To-Treat Population)
gBRCAmut Cohort non-gBRCAmut Cohort
ZEJULA
(N=138) Placebo (N=65) ZEJULA
(N=234) Placebo (N=116)
NR=Not Reached
* efficacy analysis was based on blinded central independent radiologic and clinical oncology review committee (IRC). † based on a stratified Cox proportional hazards model ‡ based on a stratified log-rank test
PFS Median in months (95% CI) 21.0
(12.9, NR) 5.5
(3.8, 7.2) 9.3
(7.2, 11.2) 3.9
(3.7, 5.5)
Hazard Ratio (HR)†
(95% CI) 0.26
(0.17, 0.41) 0.45
(0.34, 0.61)
p-value‡ <0.0001 <0.0001
Figure 1: Kaplan-Meier Plot for Progression-Free Survival in the gBRCAmut Cohort Based on IRC Assessment (ITT Population, N=203)
Figure 1
Figure 2: Kaplan-Meier Plot for Progression-Free Survival in the Non-gBRCAmut Cohort Overall Based on IRC Assessment (ITT Population, N=350)
Figure 2
At the time of the PFS analysis, limited overall survival data were available with 17% deaths across the two cohorts.
16 HOW SUPPLIED/STORAGE AND HANDLING
ZEJULA is available as capsules having a white body printed with "100 mg" in black ink, and a purple cap printed with "Niraparib" in white ink.
Each capsule contains 100 mg of niraparib free base.
ZEJULA capsules are packaged as 90-count bottles NDC 69656-103-90
Store at 20° to 25°C (68° to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
MDS/AM
Advise patients to contact their healthcare provider if they experience weakness, feeling tired, fever, weight loss, frequent infections, bruising, bleeding easily, breathlessness, blood in urine or stool, and/or laboratory findings of low blood cell counts, or a need for blood transfusions. This may be a sign of hematological toxicity or myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) which has been reported in patients treated with ZEJULA [see WARNINGS AND PRECAUTIONS (5.1)].
Bone Marrow Suppression
Advise patients that periodic monitoring of their blood counts is required. Advise patients to contact their healthcare provider for new onset of bleeding, fever, or symptoms of infection [see WARNINGS AND PRECAUTIONS (5.2)].
Cardiovascular Effects
Advise patients to undergo monthly blood pressure and heart rate monitoring for the first year of treatment and then periodically thereafter and to contact their |
