ent of patients had metastases in bone and 30% had visceral involvement. Seventy percent of patients had radiographic evidence of disease progression and 30% had PSA-only progression. Seventy percent of patients had previously received one cytotoxic chemotherapy regimen and 30% received two regimens.
The protocol pre-specified interim analysis was conducted after 552 deaths and showed a statistically significant improvement in overall survival in patients treated with ZYTIGA compared to patients in the placebo arm (Table 3 and Figure 1). An updated survival analysis was conducted when 775 deaths (97% of the planned number of deaths for final analysis) were observed. Results from this analysis were consistent with those from the interim analysis (Table 3).
Table 3: Overall Survival of Patients Treated with Either ZYTIGA or Placebo in Combination with Prednisone (Intent-to-Treat Analysis) ZYTIGA
(N=797) Placebo
(N=398)
*
P-value is derived from a log-rank test stratified by ECOG performance status score (0–1 vs. 2), pain score (absent vs. present), number of prior chemotherapy regimens (1 vs. 2), and type of disease progression (PSA only vs. radiographic).
†
Hazard Ratio is derived from a stratified proportional hazards model. Hazard ratio <1 favors ZYTIGA
Primary Survival Analysis
Deaths (%) 333 (42%) 219 (55%)
Median survival (months)
(95% CI) 14.8 (14.1, 15.4) 10.9 (10.2, 12.0)
p value * < 0.0001
Hazard ratio (95% CI) † 0.646 (0.543, 0.768)
Updated Survival Analysis
Deaths (%) 501 (63%) 274 (69%)
Median survival (months)
(95% CI) 15.8 (14.8, 17.0) 11.2 (10.4, 13.1)
Hazard ratio (95% CI) † 0.740 (0.638, 0.859)
Figure 1: Kaplan-Meier Overall Survival Curves (Intent-to-Treat Analysis)
AA= ZYTIGA
16 HOW SUPPLIED/STORAGE AND HANDLING
ZYTIGA (abiraterone acetate) 250 mg tablets are white to off-white, oval tablets debossed with AA250 on one side. ZYTIGA 250 mg tablets are available in high-density polyethylene bottles of 120 tablets.
NDC Number 57894-150-12
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].
Based on its mechanism of action, ZYTIGA may harm a developing fetus. Therefore, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves [see Use in Specific Populations (8.1)].
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
Patients should be informed that ZYTIGA and prednisone are used together and that they should not interrupt or stop either of these medications without consulting their physician.
Patients receiving GnRH agonists should be informed that they need to maintain this treatment during the course of treatment with ZYTIGA and prednisone.
Patients should be informed that ZYTIGA must not be taken with food and that no food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. They should be informed that the tablets should be swallowed whole with water. Patients should be informed that taking ZYTIGA with food causes increased exposure and this may result in adverse reactions.
Patients should be informed th |
