acceptable, in the light of the limited data available with the product, not to include these as missing information items. Recommendation 5. No study The sponsor has provided The sponsors synopsis/ protocol has been information regarding response and attached for the pregnancy activities. approach is surveillance program, the acceptable in the Of note the previously lactation surveillance program, context of this proposed observational study the observational clinical study to evaluation. to estimate the frequency of assess medication errors and the However, the medication errors has been paediatric studies. The sponsor details of the deemed unfeasible and should provide more details observational medication error will instead regarding these additional study cannot be by captured in the European pharmacovigilance activities and assessed at this observational patient Study should provide these protocols time. 20150136. A protocol is not for review. yet available for this study. Once the protocol for These changes have been Study 20150136 incorporated into the revised is finalised, RMP. relevant details should be included in an update to the RMP. Recommendation 6: It is As in clinical trials, safety The evaluator recommended that the sponsor information received in the accepts the implements further activities to postmarketing setting is sponsor’s ensure comprehensive collection processed and evaluated justification that and reporting of adverse events, critically. Following the the post-market this may include but not limited review of reported cases, if observational to, implementation of: additional information is in the EU required or needed, Amgen will be generally 1) Follow-up questionnaires for will attempt to request applicable to the identified/potential safety further information from the Australian concerns, and/or; reporters. In some cases, context. 2) Patient registries in Australia. reporters would not allow The RMP should additional queries to be made be updated once and no follow-up is possible. details of this Due to the nature of activity are spontaneous reporting, further questionnaires for developed and identified/potential safety the results concerns have not been should be proposed. communicated A post-marketing observation to the TGA in an patient registry has been appropriate proposed for countries in the manner. EU; the final protocol is under development The objective of this study is to characterise the safety profile of blinatumomab in routine clinical practice by estimating the incidence of specific
acceptable, in the light of the limited data available with the product, not to include these as missing information items. Recommendation 5. No study synopsis/ protocol has been attached for the pregnancy surveillance program, the lactation surveillance program, the observational clinical study to assess medication errors and the paediatric studies. The sponsor should provide more details regarding these additional pharmacovigilance activities and should provide these protocols for review. The sponsor has provided information regarding activities. Of note the previously proposed observational study to estimate the frequency of medication errors has been deemed unfeasible and medication error will instead by captured in the European observational patient Study 20150136. A protocol is not yet available for this study. These changes have been incorporated into the revised RMP. The sponsors response and approach is acceptable in the context of this evaluation. However, the details of the observational study cannot be assessed at this time. Once the protocol for Study 20150136 is finalised, relevant details should be included in an update to the RMP. Recommendation 6: It is recommended that the sponsor implements further activities to ensure comprehensive collection and reporting of adverse events, this may include but not limited to, implementation of: 1) Follow-up questionnaires for identified/potential safety concerns, and/or; 2) Patient registries in Australia. As in clinical trials, safety information received in the postmarketing setting is processed and evaluated critically. Following the review of reported cases, if additional information is required or needed, Amgen will attempt to request further information from the reporters. In some cases, reporters would not allow additional queries to be made and no follow-up is possible. Due to the nature of spontaneous reporting, questionnaires for identified/potential safety concerns have not been proposed. A post-marketing observation patient registry has been proposed for countries in the EU; the final protocol is under development The objective of this study is to characterise the safety profile of blinatumomab in routine clinical practice by estimating the incidence of specific The evaluator accepts the sponsor’s justification that the post-market observational in the EU will be generally applicable to the Australian context. The RMP should be updated once details of this activity are further developed and the results should be communicated to the TGA in an appropriate manner.