who are scheduled for first chemotherapy. Obtain long-term Missing information: Long-term effects of Protocol follow up information long-term effects of bevacizumab when submission Q4 from studies in the bevacizumab when used in the 2017 paediatric population used in the paediatric paediatric population after patients population. complete their 5.5 years of follow up in Study BO20924 (planned) A monitoring plan” is also implemented in all breast cancer studies for the “safety important identified risk heart failure’. This includes regular left ventricle ‘congestive ejection fraction monitoring and cardiology input in data and safety monitoring boards. Risk minimisation activities Routine risk minimisation is proposed by the sponsor to mitigate all safety concerns. No additional risk minimisation activities are proposed. Reconciliation of issues outlined in the RMP report Table 6 summarises the first round evaluation of the RMP, the sponsor’s responses to issues raised and the RMP evaluator’s evaluation of the sponsor’s responses. Table 6: Reconciliation of issues outlined in the RMP report Recommendation in RMP Sponsor’s response (or RMP evaluation report summary of the response) evaluator’s comment Safety considerations may be raised The sponsor acknowledges this The by the clinical evaluator through the requirement. No new risks are sponsor’s TGA consolidated request for required to be added to the RMP response is information and/or the CER as a consequence of the additional noted. respectively. It is important to information provided in this ensure that the information response. provided in response to includes a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. The EU-RMP also includes a The sponsor confirms the The questionnaire for adverse events up questionnaire for sponsor’s relating to important identified risk of the jaw’ is assurance is ‘osteonecrosis of the jaw’ is not undertaken in Australia. The noted. ‘osteonecrosis proposed in the ASA. The sponsor sponsor provides the assurance should confirm that this activity is
who are scheduled for first chemotherapy. Obtain long-term follow up information from studies in the paediatric population after patients complete their 5.5 years of follow up in Study BO20924 (planned) Missing information: long-term effects of bevacizumab when used in the paediatric population. Long-term effects of bevacizumab when used in the paediatric population Protocol submission Q4 2017 A “safety monitoring plan” is also implemented in all breast cancer studies for the important identified risk ‘congestive heart failure’. This includes regular left ventricle ejection fraction monitoring and cardiology input in data and safety monitoring boards. Risk minimisation activities Routine risk minimisation is proposed by the sponsor to mitigate all safety concerns. No additional risk minimisation activities are proposed. Reconciliation of issues outlined in the RMP report Table 6 summarises the first round evaluation of the RMP, the sponsor’s responses to issues raised and the RMP evaluator’s evaluation of the sponsor’s responses. Table 6: Reconciliation of issues outlined in the RMP report Recommendation in RMP evaluation report Sponsor’s response (or summary of the response) RMP evaluator’s comment Safety considerations may be raised by the clinical evaluator through the TGA consolidated request for information and/or the CER respectively. It is important to ensure that the information provided in response to includes a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. The sponsor acknowledges this requirement. No new risks are required to be added to the RMP as a consequence of the additional information provided in this response. The sponsor’s response is noted. The EU-RMP also includes a questionnaire for adverse events relating to important identified risk ‘osteonecrosis of the jaw’ is not proposed in the ASA. The sponsor should confirm that this activity is The sponsor confirms the questionnaire for ‘osteonecrosis of the jaw’ is undertaken in Australia. The sponsor provides the assurance The sponsor’s assurance is noted. up
auspar-bevacizumab-rch-170510.docx