The conversion to the new EU RMP template also lead to deletion of the following text: Potential for Overdose. Epidemiology of the target population unexposed to the product. Epidemiology of safety concerns in target population. Table of study exclusion criteria. Projection post-authorisation usage. Update to the RMP The list of breast cancer studies with This is acceptable. It For the safety concern sequential regular LVEF monitoring, is recommended that of heart ‘congestive cardiology expert in DSMB and CHF guided the sponsor include failure’ the sponsor questionnaires are listed below. Protocols for the titles of these makes the following these studies have been enclosed in module studies within the statement regarding 2.7.6. pharmacovigilance additional plan in the RMP and pharmacovigilance: BO20289 (BEATRICE) ASA. monitoring plan ‘Safety Title: An international multi-centre open-label implemented in 2-arm Phase III of adjuvant bevacizumab ongoing/planned in negative’ breast cancer. ‘triple breast cancer studies sequential regular Milestone: Primary analysis completed July LVEF monitoring in 2012, patients on follow up for OS analysis breast cancer studies BO20906/AVF4285s (BETH) study: cardiology expert in DSMBs guided Title: A Multicenter Phase III Randomized questionnaire’. It is of Adjuvant Therapy for Patients with recommended that the Node-Positive or High Risk sponsor clarify exactly Breast Cancer Comparing what studies they are Chemotherapy Plus Trastuzumab with referring to, the study Chemotherapy Plus Trastuzumab Plus titles, milestones and Bevacizumab submit protocols for Milestone: Ongoing Primary analysis any planned studies to – planned Q4 2013 the TGA for review. BO20231 (AVEREL) study: Title: A randomized, open-label, 2-arm, multicentre, Phase III study to evaluate the efficacy and safety of bevacizumab in combination with trastuzumab/docetaxel compared with trastuzumab/docetaxel alone as first line treatment for patients with HER2 positive locally recurrent or metastatic breast cancer. Milestone: Primary analysis completed October 2011, end of study planned first quarter 2014
The conversion to the new EU RMP template also lead to deletion of the following text: Potential for Overdose. Epidemiology of the target population unexposed to the product. Epidemiology of safety concerns in target population. Table of study exclusion criteria. Projection post-authorisation usage. Update to the RMP For the safety concern of ‘congestive heart failure’ the sponsor makes the following statement regarding additional pharmacovigilance: ‘Safety monitoring plan implemented in ongoing/planned breast cancer studies sequential regular LVEF monitoring in breast cancer studies cardiology expert in DSMBs guided questionnaire’. It is recommended that the sponsor clarify exactly what studies they are referring to, the study titles, milestones and submit protocols for any planned studies to the TGA for review. The list of breast cancer studies with sequential regular LVEF monitoring, cardiology expert in DSMB and CHF guided questionnaires are listed below. Protocols for these studies have been enclosed in module 2.7.6. BO20289 (BEATRICE) Title: An international multi-centre open-label 2-arm Phase III of adjuvant bevacizumab in ‘triple negative’ breast cancer. Milestone: Primary analysis completed July 2012, patients on follow up for OS analysis BO20906/AVF4285s (BETH) study: Title: A Multicenter Phase III Randomized of Adjuvant Therapy for Patients with Node-Positive or High Risk Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab Milestone: Ongoing – Primary analysis planned Q4 2013 BO20231 (AVEREL) study: Title: A randomized, open-label, 2-arm, multicentre, Phase III study to evaluate the efficacy and safety of bevacizumab in combination with trastuzumab/docetaxel compared with trastuzumab/docetaxel alone as first line treatment for patients with HER2 positive locally recurrent or metastatic breast cancer. Milestone: Primary analysis completed October 2011, end of study planned first quarter 2014 This is acceptable. It is recommended that the sponsor include the titles of these studies within the pharmacovigilance plan in the RMP and ASA.
auspar-bevacizumab-141103.docx