AusPAR: Cabazitaxel - Therapeutic Goods Administration

AusPAR Jevtana Cabazitaxel Sanofi-Aventis Australia Pty Ltd PM-2010-02565-3-4
Final 9 February 2012
Therapeutic Goods Administration
In the combination study (TCD 6945), the incidence of Grade 3-4 TEAEs was 69.7%.
Serious adverse events were reported in 51.5% of the patients. The distribution of TEAEs
was similar to that in the pivotal study. The incidence of neutropenia was 21.2% and
similar to that reported in the pivotal study.
Deaths and other serious adverse events
Pivotal study
By the cut-off date (25 September 2009), 227 patients (61.2%) in the cabazitaxel arm and
275 patients (74.1%) in the mitoxantrone arm had died. Progressive disease was the cause
of death in 53.1% of deaths in the cabazitaxel arm and 68.2% of deaths in the
mitoxantrone arm. In the cabazitaxel arm, 18 (4.9%) died from TEAE within 30 days of
last infusion, compared with 7 (1.9%) in the mitoxantrone arm (Table 12). Deaths from
TEAEs in the cabazitaxel arm included infection and cardiac disease (Table 13).
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