pharmacovigilance plan to include the PIP study of the RMP. as a pharmacovigilance activity to address the missing information of in use in ‘Safety paediatric patients’. Furthermore, the sponsor agrees to include the available study protocol for the PIP in an annex to the EU RMP v1.1, and future PIP study protocols will be added when available. As the safety data base is The sponsor requests A.) The sponsor’s relatively small, it is follow up information on commitment to recommended that the spontaneous adverse implement additional sponsor implements event reports received follow-up forms to further for pembrolizumab collect important pharmacovigilance utilizing Standard information on the activities, to ensure the Operating Procedures. In identified and potential safe use of the product, addition, the sponsor risks, immune related should it be approved. agrees to utilise an events and infusion This includes, but is not additional follow-up related reactions, limited to: A.) form to collect reported with Implementation of important information pembrolizumab has follow-up forms for all on the identified and been noted. It is identified and potential potential risks, immune recommended that these risks, in order to collect related events and additional follow-up comprehensive infusion related forms are included in the information about the reactions, reported with pharmacovigilance plan causality and outcome of pembrolizumab as part of the RMP, and are adverse events. B.) of routine attached to an updated Implementation of a pharmacovigilance RMP as an annex. Post Authorisation activities. B.) The recommendation Safety Study (PASS) to Although the initial to implement additional collect detailed cohort for which safety pharmacovigilance information about the assessments have been activities remains and is safety profile of the the basis of the RMP is supported by ACSOM. product. generally small, the sponsor believes that a PASS is not necessary at this time given the number of on-going clinical trials with pembrolizumab and the planned studies across all indications from which valuable safety information will be obtained. Specifically,
pharmacovigilance plan of the RMP. to include the PIP study as a pharmacovigilance activity to address the missing information of ‘Safety in use in paediatric patients’. Furthermore, the sponsor agrees to include the available study protocol for the PIP in an annex to the EU RMP v1.1, and future PIP study protocols will be added when available. As the safety data base is relatively small, it is recommended that the sponsor implements further pharmacovigilance activities, to ensure the safe use of the product, should it be approved. This includes, but is not limited to: A.) Implementation of follow-up forms for all identified and potential risks, in order to collect comprehensive information about the causality and outcome of adverse events. B.) Implementation of a Post Authorisation Safety Study (PASS) to collect detailed information about the safety profile of the product. The sponsor requests follow up information on spontaneous adverse event reports received for pembrolizumab utilizing Standard Operating Procedures. In addition, the sponsor agrees to utilise an additional follow-up form to collect important information on the identified and potential risks, immune related events and infusion related reactions, reported with pembrolizumab as part of routine pharmacovigilance activities. Although the initial cohort for which safety assessments have been the basis of the RMP is generally small, the sponsor believes that a PASS is not necessary at this time given the number of on-going clinical trials with pembrolizumab and the planned studies across all indications from which valuable safety information will be obtained. Specifically, A.) The sponsor’s commitment to implement additional follow-up forms to collect important information on the identified and potential risks, immune related events and infusion related reactions, reported with pembrolizumab has been noted. It is recommended that these additional follow-up forms are included in the pharmacovigilance plan of the RMP, and are attached to an updated RMP as an annex. B.) The recommendation to implement additional pharmacovigilance activities remains and is supported by ACSOM.
auspar-pembrolizumab-rch-161014.docx