AusPAR: Cabazitaxel - Therapeutic Goods Administration

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Figure 6: Kaplan-Meier curves for PFS – ITT population AusPAR Jevtana Cabazitaxel Sanofi-Aventis Australia Pty Ltd PM-2010-02565-3-4 Final 9 February 2012 Therapeutic Goods Administration Overall tumour response rate (objective response) This was evaluated only in patients with measurable disease (arm A: 204 patients [54.1%], arm B: 201patients [53.2%]). The ORR was 4.4% in arm A and 14.4% in arm B (p=0.0005). Time to tumour progression The median time to tumour progression, calculated in all the randomized patients, was 5.4 months in arm A and 8.8 months in arm B (p
AusPAR Jevtana Cabazitaxel Sanofi-Aventis Australia Pty Ltd PM-2010-02565-3-4 Final 9 February 2012 Therapeutic Goods Administration Figure 7: Kaplan-Meier curves of time to tumour progression – ITT population PSA progression PSA progression was statistically significantly longer in the cabazitaxel arm (6.4 months) than in the mitoxantrone arm (3.1 months, P=0.0010). The HR was 0.75 (95% CI: 0.63- 0.90), corresponding to a 25% reduction in the risk of PSA progression (Figure 8). Similar numbers of patients (13 and 12 respectively in arms A and B) had skipped/delayed visits for PSA. Two sensitivity analyses were conducted and showed that the results were similar to the primary analysis (HR: 0.75 and 0.76). Figure 8: Kaplan-Meier curves of PSA progression – ITT population Page 37 of 75
Page 1 and 2: Australian Public Assessment Report
Page 3 and 4: Contents AusPAR Jevtana Cabazitaxel
Page 5 and 6: AusPAR Jevtana Cabazitaxel Sanofi-A
Page 7 and 8: Acetone Solvate AusPAR Jevtana Caba
Page 17 and 18: Toxicological effects typical of th
Page 19 and 20: Reproductive toxicity AusPAR Jevtan
Page 21 and 22: Table 3: Details of impurities test
Page 29 and 30: Figure 1: Flow chart AusPAR Jevtana
Page 33 and 34: Figure 2: Overall survival (OS) - I
Page 35: AusPAR Jevtana Cabazitaxel Sanofi-A
Page 55 and 56: Safety AusPAR Jevtana Cabazitaxel S
Page 59 and 60: NAME OF THE MEDICINE Non-proprietar
Page 61 and 62: CLINICAL TRIALS The efficacy and sa
Page 63 and 64: Table 2 Efficacy of Jevtana in the
Page 65 and 66: Risk of cardiac arrhythmias Cardiac
Page 67 and 68: co-administration with CYP3A induce
Page 69 and 70: System Organ Class Adverse Reaction
Page 71 and 72: none of which were Grade ≥3. The
Page 73 and 74: Table 4 Recommended Dosage Modifica
Page 75: Therapeutic Goods Administration PO

AusPAR: Cabazitaxel - Therapeutic Goods Administration

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