I. Introduction to product submission Submission details Type of submission: Major variation (new indication) Decision: Approved Date of decision: 16 July 2015 Date of entry onto ARTG 23 July 2015 Active ingredient(s): Bevacizumab (rch) Product name(s): Avastin Sponsor’s name and address: Roche Products Pty Ltd PO Box 255 4-10 Innman Road Dee Why NSW 2099 Dose form: Injection, concentrated Strengths: 100 mg/ 4 mL and 400 mg/ 16 mL Container: vial Pack size: 1 vial Approved therapeutic use: In combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. In combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated. Route of administration: intravenous Dosage: AVASTIN is administered in combination with paclitaxel and cisplatin or, if cisplatin is not tolerated or not indicated, paclitaxel and topotecan (see the Product Information for further details on the chemotherapy regimens). The recommended dose of AVASTIN is 15 mg/kg of body weight given once every 3 weeks as an intravenous (IV) infusion. ARTG numbers: 99756 and 99757 Product background This AusPAR describes the application by the sponsor to register Avastin bevacizumab (rch) for the following indication: AVASTIN (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent or IV carcinoma of the cervix.
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