these trials. For the purpose of providing safety updates from clinical trials to the TGA, the sponsor confirms that Periodic Safety Update Reports (PSUR), as outlined in the EMA will ‘Guideline be provided on a 6 monthly basis. The PSURs will contain all safety data collected by the sponsor, including data from clinical trials and in-market use in territories where Keytruda is approved. Changes to the safety profile of Keytruda will be communicated via changes in labelling, individual case reporting and the periodic PSURs. It appears that safety The sponsor agrees to The sponsor’s response related data which will update Table 46 cannot be verified be collected during of because no updated ‘Overview ongoing clinical studies Pharmacovigilance RMP was provided with will address some of the Actions’ in the current the response. ongoing safety concerns. EU RMP v1.1 to reflect It is recommended that Consequently, it is generally the current the sponsor provides the recommended that the clinical trials as updated RMP for review sponsor amends table they will contribute prior to approval. 46 of the EU-RMP important safety data to (Overview of the overall Pharmacovigilance understanding of Actions), and any other ongoing safety concerns table as appropriate, to assign safety concerns to the ongoing clinical studies. The study protocols for Section SIV.3 The sponsor’s response the PIP have not been in Respect cannot be verified ‘Limitations attached to the RMP, and to Populations Typically because no updated it is recommended that Under-represented in RMP was provided with the sponsor provides Clinical the response. these as annex to the Development It is recommended that Furthermore, Programmes’ and Table the sponsor provides the these studies should be 49 of ‘Overview updated RMP for review assigned to the ongoing Pharmacovigilance prior to approval. safety concerns of safety Actions’ of the EU RMP in paediatrics in the v.1.1 have been updated
these trials. For the purpose of providing safety updates from clinical trials to the TGA, the sponsor confirms that Periodic Safety Update Reports (PSUR), as outlined in the EMA ‘Guideline will be provided on a 6 monthly basis. The PSURs will contain all safety data collected by the sponsor, including data from clinical trials and in-market use in territories where Keytruda is approved. Changes to the safety profile of Keytruda will be communicated via changes in labelling, individual case reporting and the periodic PSURs. It appears that safety related data which will be collected during ongoing clinical studies will address some of the ongoing safety concerns. Consequently, it is recommended that the sponsor amends table 46 of the EU-RMP (Overview of Pharmacovigilance Actions), and any other table as appropriate, to assign safety concerns to the ongoing clinical studies. The sponsor agrees to update Table 46 ‘Overview of Pharmacovigilance Actions’ in the current EU RMP v1.1 to reflect generally the current clinical trials as they will contribute important safety data to the overall understanding of ongoing safety concerns The sponsor’s response cannot be verified because no updated RMP was provided with the response. It is recommended that the sponsor provides the updated RMP for review prior to approval. The study protocols for the PIP have not been attached to the RMP, and it is recommended that the sponsor provides these as annex to the Furthermore, these studies should be assigned to the ongoing safety concerns of safety in paediatrics in the Section SIV.3 ‘Limitations in Respect to Populations Typically Under-represented in Clinical Development Programmes’ and Table 49 ‘Overview of Pharmacovigilance Actions’ of the EU RMP v.1.1 have been updated The sponsor’s response cannot be verified because no updated RMP was provided with the response. It is recommended that the sponsor provides the updated RMP for review prior to approval.
auspar-pembrolizumab-rch-161014.docx