AusPAR: Cabazitaxel - Therapeutic Goods Administration

6. Lens toxicity was observed in nonclinical studies in rats.
Assessment of benefit-risk balance
AusPAR Jevtana Cabazitaxel Sanofi-Aventis Australia Pty Ltd PM-2010-02565-3-4
Final 9 February 2012
Therapeutic Goods Administration
The benefit risk balance of cabazitaxel given the proposed usage is favourable.
V. Pharmacovigilance Findings
Risk Management Plan
Safety Specification
The sponsor submitted a Risk Management Plan which was reviewed by the TGA’s Office
of Product Review (OPR). The summary of the Ongoing Safety Concerns as specified by the
sponsor is shown at Table 15.
Table 15: Ongoing safety concerns for cabazitaxel
The nonclinical evaluator noted that most relevant nonclinical findings have been
identified and adequately described in the safety specification in the Risk Management
Plan (RMP). The only exception is the description of ocular findings. It states that
lenticular changes were “partially reversible after the 2 month recovery period”.
According to the submitted toxicity studies, there was no indication of reversibility of
ocular findings. Furthermore, ocular findings were observed at clinically relevant
exposures. The ocular findings are of unknown clinical relevance, but to remain cautious,
they should be considered potentially relevant to human use. Appropriate modification of
this section of the safety specification was recommended.
The OPR reviewer noted the summary of the Ongoing Safety Concerns was acceptable.
Pharmacovigilance Plan
The sponsor proposed routine pharmacovigilance activities to monitor all the specified
ongoing safety concerns. 22
22 Routine pharmacovigilance practices involve the following activities:
• All suspected adverse reactions that are reported to the personnel of the company are collected and
collated in an accessible manner;
• Reporting to regulatory authorities;
• Continuous monitoring of the safety profiles of approved products including signal detection and
updating of labeling;
• Submission of PSURs;
• Meeting other local regulatory agency requirements.
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