Study B021990 Wound healing To investigate the CSR 2013 efficacy and safety of complications (Submitted as part of (AVAglio) bevacizumab, this filing) temozolomide and (ongoing) radiotherapy followed by 6 cycles maintenance with bevacizumab and temozolomide as compared to placebo, temozolomide, and radiotherapy followed by 6 cycles maintenance with placebo and temozolomide. Study NSABP C-08 Study title: Fluorouracil, Wound healing Estimated study end Leucovorin, and complications 2014. Final report due (ongoing) Oxaliplatin With or 2015. (Note: the Without Bevacizumab in pharmacovigilance plan Treating Patients Who does not assign other Have Undergone Surgery safety concerns to this for Colon Cancer. study, however the Objectives: to RMP does assign other characterise the risks to this study. comparative incidence of delayed vascular events in bevacizumabtreated patients following the discontinuation of bevacizumab and in concurrently enrolled control patients. BO20924 Physeal dysokasia: open-label, multi-centre, CSR expected first Clinical significance in randomised Phase II trial quarter 2016. BERNIE) in children and paediatric patients Final report due first adolescents with (ongoing) Long-term effects of quarter 2017 metastatic bevacizumab when rhabdomyosarcoma and used in the paediatric non-rhabdomyosarcoma population. soft tissue sarcoma to assess addition of bevacizumab to chemotherapy CSR=company study report; DSMBs=Data and Safety Monitoring Board Risk minimisation activities Routine risk minimisation activities are proposed for all safety concerns except for one area of missing information profile of the different treatment combination in patients ‘safety with non-squamous NSCLC’. It is recommended that the ASA be revised to comply with the standard format specified in the TGA RMP Questions and Answers. This includes information on Australian specific epidemiological data. Furthermore, the sponsor should include the following within the ASA:
Study B021990 (AVAglio) (ongoing) Wound healing complications To investigate the efficacy and safety of bevacizumab, temozolomide and radiotherapy followed by 6 cycles maintenance with bevacizumab and temozolomide as compared to placebo, temozolomide, and radiotherapy followed by 6 cycles maintenance with placebo and temozolomide. CSR 2013 (Submitted as part of this filing) Study NSABP C-08 (ongoing) Wound healing complications (Note: the pharmacovigilance plan does not assign other safety concerns to this study, however the RMP does assign other risks to this study. Study title: Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Colon Cancer. Objectives: to characterise the comparative incidence of delayed vascular events in bevacizumabtreated patients following the discontinuation of bevacizumab and in concurrently enrolled control patients. Estimated study end 2014. Final report due 2015. BO20924 BERNIE) (ongoing) Physeal dysokasia: Clinical significance in paediatric patients Long-term effects of bevacizumab when used in the paediatric population. open-label, multi-centre, randomised Phase II trial in children and adolescents with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma to assess addition of bevacizumab to chemotherapy CSR expected first quarter 2016. Final report due first quarter 2017 CSR=company study report; DSMBs=Data and Safety Monitoring Board Risk minimisation activities Routine risk minimisation activities are proposed for all safety concerns except for one area of missing information ‘safety profile of the different treatment combination in patients with non-squamous NSCLC’. It is recommended that the ASA be revised to comply with the standard format specified in the TGA RMP Questions and Answers. This includes information on Australian specific epidemiological data. Furthermore, the sponsor should include the following within the ASA:
auspar-bevacizumab-141103.docx