AusPAR: Cabazitaxel - Therapeutic Goods Administration

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AusPAR Jevtana Cabazitaxel Sanofi-Aventis Australia Pty Ltd PM-2010-02565-3-4 Final 9 February 2012 Therapeutic Goods Administration Figure 4: Hazard ratio of OS for docetaxel dose and progression – CBZ+PRED vs MXT+PRED – ITT population The subgroups to show a HR of 1 were 'patients with a prior docetaxel dose of < 225 mg/m2' and 'other countries'. The number of 'patients with a prior docetaxel dose of < 225 mg/m2' was small (59) and may be the reason for the HR of 1. The 'other countries' were made up of 9 countries with 28 study sites. Some had statistically significant HRs and others not. ECOG performance status at baseline, measurability of disease at baseline, time from last dose of docetaxel to randomization, time of progression after last docetaxel treatment and pain score at baseline were significant prognostic factors (Table 6). Table 6: Univariate analysis of prognostic factors and their interaction on OS - ITT population The impact of liver function on OS was examined. The Cox proportional hazard model showed a statistically significant benefit in OS for cabazitaxel treatment but the Page 34 of 75
AusPAR Jevtana Cabazitaxel Sanofi-Aventis Australia Pty Ltd PM-2010-02565-3-4 Final 9 February 2012 Therapeutic Goods Administration interaction of treatment and liver function test on OS was not statistically significant (p=0.9909). This would suggest that cabazitaxel treatment benefit over mitoxantrone treatment was not influenced by the patients liver function (Figure 5). Figure 5: Kaplan-Meier curves of OS (months) by treatment group and baseline liver function – ITT population Results for other efficacy outcomes Progression free survival (PFS) PFS was defined per protocol as a composite endpoint evaluated from the day of randomisation to the date of tumour progression, PSA progression, pain progression, or death due to any cause, whichever occurred first. The sponsor claims that 20% of the patients in each arm reported pain progression as the criterion for PFS. The median PFS was 1.4 months in arm A and 2.8 months in arm B. The difference was statistically significant in favour of the cabazitaxel arm. The HR was 0.74 (95% CI: 0.64-0.86) corresponding to a 26% reduction in risk of death in the cabazitaxel arm (Figure 6). Two sensitivity analyses were performed to assess the impact of 9 patients in arm A and 6 patients in arm B who were not assessed or had delayed assessment of PFS. The results of these analyses confirmed a HR 0.74 for both analyses. Page 35 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: Figure 2: Overall survival (OS) - I
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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