Patient Information minimization (the PI) considers routine risk Brochures including adequate for the minimization (the PI) alert cards. pembrolizumab RMP. adequate for the Based on the current pembrolizumab RMP. In benefit: risk profile for contrast the sponsor pembrolizumab, there is also states: The sponsor no evidence that will be providing additional risk educational materials to minimization activities prescribers and patient beyond those planned information that will by the sponsor are enhance the product warranted. The PI labelling awareness for comprehensively pembrolizumab. communicates risks for The sponsor should pembrolizumab and clarify if educational provides clear guidance materials for physicians for identification, and patients will form treatment of the risks part of the RMP, and if associated with so, this activity should pembrolizumab, and be incorporated in the recommendations for risk-minimisation plan discontinuation or of the RMP and these temporary interruption documents attached to of therapy accordingly to the updated RMP as an the severity by observed annex. risk. The sponsor will be B.) Pending the providing educational clarification by the materials to prescribers sponsor, the and patient information recommendation to that will enhance the implement additional product labelling risk-minimisation awareness for activities remains and is pembrolizumab. The supported by sponsor also considers that the oncology community is now familiar with immunotherapy for melanoma. Adoption of appropriate patient management for a new oncology product into treatment practices will be adequately supported by labelling with product specific educational materials provided by the sponsor to support product launch. It is recommended that Part V The sponsor’s response ‘Risk the sponsor amends Minimization Measures’, cannot be verified table 65 of the EU-RMP V.3 Table of because no updated ‘Summary
Patient Information Brochures including alert cards. minimization (the PI) adequate for the pembrolizumab RMP. Based on the current benefit: risk profile for pembrolizumab, there is no evidence that additional risk minimization activities beyond those planned by the sponsor are warranted. The PI comprehensively communicates risks for pembrolizumab and provides clear guidance for identification, treatment of the risks associated with pembrolizumab, and recommendations for discontinuation or temporary interruption of therapy accordingly to the severity by observed risk. The sponsor will be providing educational materials to prescribers and patient information that will enhance the product labelling awareness for pembrolizumab. The sponsor also considers that the oncology community is now familiar with immunotherapy for melanoma. Adoption of appropriate patient management for a new oncology product into treatment practices will be adequately supported by labelling with product specific educational materials provided by the sponsor to support product launch. considers routine risk minimization (the PI) adequate for the pembrolizumab RMP. In contrast the sponsor also states: The sponsor will be providing educational materials to prescribers and patient information that will enhance the product labelling awareness for pembrolizumab. The sponsor should clarify if educational materials for physicians and patients will form part of the RMP, and if so, this activity should be incorporated in the risk-minimisation plan of the RMP and these documents attached to the updated RMP as an annex. B.) Pending the clarification by the sponsor, the recommendation to implement additional risk-minimisation activities remains and is supported by It is recommended that the sponsor amends table 65 of the EU-RMP Part V ‘Risk Minimization Measures’, V.3 ‘Summary Table of The sponsor’s response cannot be verified because no updated
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