to include 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 DLP of It is noted that Recommendation 2: A copy of the current EU-RMP, the submitted RMP is 10 October Version 1.2 dated 13 August the DLP remains 2013. It is recommended that the 2015 is provided, together the same as the sponsor submits a more up to with an updated ASA. previous version. date version of the EU-RMP with their response to TGA questions. This is Recommendation 3: In the RMP evaluation report Amendments to the table of the evaluator includes the acceptable from ongoing safety concerns as following comment: an RMP detailed in the RMP evaluation perspective. 1) Currently no long term (> report. 12 months) safety data is available and therefore, this should be added as missing information. 2) Hypersensitivity/ Immunogenicity should be added as a potential risk. The updated European RMP (Version 1.2) provided includes long term safety as ‘Missing Information’, and Immunogenicity as an Potential Risk’, in ‘Important line with current safety knowledge. This is also reflected in the ASA. Recommendation 4: In a of The sponsor has provided the This is the EU-RMP (Exclusion Criteria requested information and acceptable from That are Not Proposed to Remain justification. an RMP as Contraindications) the sponsor perspective. It is noted that the most describes exclusion criteria for recent RMP now includes the clinical development program several of these criteria as where no data is available. It is missing information. noted that many of these criteria are of relevance to clinical practice, especially as the indication sought is not a first line indication and therefore, patients are expected to have received prior treatment. The sponsor should elaborate on all criteria described in this table, and provide detailed justification as to why it would be considered
to include 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. Recommendation 2: The DLP of the submitted RMP is 10 October 2013. It is recommended that the sponsor submits a more up to date version of the EU-RMP with their response to TGA questions. A copy of the current EU-RMP, Version 1.2 dated 13 August 2015 is provided, together with an updated ASA. It is noted that the DLP remains the same as the previous version. Recommendation 3: Amendments to the table of ongoing safety concerns as detailed in the RMP evaluation report. In the RMP evaluation report the evaluator includes the following comment: 1) Currently no long term (> 12 months) safety data is available and therefore, this should be added as missing information. 2) Hypersensitivity/ Immunogenicity should be added as a potential risk. The updated European RMP (Version 1.2) provided includes long term safety as ‘Missing Information’, and Immunogenicity as an ‘Important Potential Risk’, in line with current safety knowledge. This is also reflected in the ASA. This is acceptable from an RMP perspective. Recommendation 4: In a of the EU-RMP (Exclusion Criteria That are Not Proposed to Remain as Contraindications) the sponsor describes exclusion criteria for the clinical development program where no data is available. It is noted that many of these criteria are of relevance to clinical practice, especially as the indication sought is not a first line indication and therefore, patients are expected to have received prior treatment. The sponsor should elaborate on all criteria described in this table, and provide detailed justification as to why it would be considered The sponsor has provided the requested information and justification. It is noted that the most recent RMP now includes several of these criteria as missing information. This is acceptable from an RMP perspective.
auspar-blinatumomab-180207.docx