A total of 755 patients were randomized to receive either JEVTANA 25 mg/m intravenously every 3 weeks for a maximum of 10 cycles with prednisone 10 mg orally daily (n=378), or to receive mitoxantrone 12 mg/m intravenously every 3 weeks for 10 cycles with prednisone 10 mg orally daily (n=377) for a maximum of 10 cycles.

This study included patients over 18 years of age with hormone-refractory metastatic prostate cancer either measurable by RECIST criteria or non-measurable disease with rising PSA levels or appearance of new lesions, and ECOG (Eastern Cooperative Oncology Group) performance status 0–2. Patients had to have neutrophils >1,500 cells/mm, platelets > 100,000 cells/mm, hemoglobin > 10 g/dL, creatinine < 1.5 × upper limit of normal (ULN), total bilirubin < 1×ULN, AST < 1.5 × ULN, and ALT < 1.5 × ULN. Patients with a history of congestive heart failure, or myocardial infarction within the last 6 months, or patients with uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension were not included in the study.

Demographics, including age, race, and ECOG performance status (0–2) were balanced between the treatment arms. The median age was 68 years (range 46–92) and the racial distribution for all groups was 83.9% Caucasian, 6.9% Asian, 5.3% Black, and 4% Others in the JEVTANA group.

Efficacy results for the JEVTANA arm versus the control arm are summarized in Table 3 and Figure 1.

Investigator-assessed tumor response of 14.4% (95%CI: 9.6–19.3) was higher for patients in the JEVTANA arm compared to 4.4% (95%CI: 1.6–7.2) for patients in the mitoxantrone arm, p=0.0005.

Table 3 - Efficacy of JEVTANA in the Treatment of Patients with Hormone Refractory Metastatic Prostate Cancer (Intent-to-Treat Analysis)   JEVTANA + Prednisone
n=378 Mitoxantrone + Prednisone
n=377
Overall Survival   
Number of deaths (%) 234 (61.9 %) 279 (74%)
Median survival (month) (95% CI) 15.1 (14.1–16.3) 12.7 (11.6–13.7)
Hazard RatioHazard ratio estimated using Cox model; a hazard ratio of less than 1 favors JEVTANA (95% CI) 0.70 (0.59–0.83)
p-value <0.0001
Figure 1 - Kaplan-Meier Overall Survival Curves 
 

JEVTANA is supplied as a kit containing one single-use vial of JEVTANA (cabazitaxel) Injection (clear glass vial with a grey rubber closure, aluminum cap and light green plastic flip-off cap) and one vial of Diluent for JEVTANA (13% (w/w) ethanol in water for injection) in a clear glass vial with a grey rubber closure, gold-color aluminum cap and colorless plastic flip-off cap. Both items are in a blister pack in one carton.

NDC 0024-5824-11

JEVTANA Injection and Diluent for JEVTANA:

Store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F).

Do not refrigerate.

Stability of the First Diluted Solution in the Vial:

First diluted solution of JEVTANA should be used immediately (within 30 minutes). Discard any unused portion [see Dosage and Administration (2.5)].

Stability of the Second (Final) Dilution Solution in the Infusion Bag:

Fully prepared JEVTANA in