(Summary of Safety Risk Minimization RMP was provided with Concerns and Risk Measures’, Table 73 the response. Minimization Activities) of Safety ‘Summary It is recommended that to describe only Concerns and Risk the sponsor provides the activities Minimization Activities’ updated RMP for review but not of the EU-RMP has been to approval. pharmacovigilance modified and includes activities. the routine risk minimization activities for each listed safety concern. A table comparing the A table comparing the The trial has been wording in the proposed EU SmPC, US provided by the sponsor. Australian-PI with the monograph and the This is considered EU-SmPC should be proposed Australian PI acceptable. provided as annex to the is provided as an ASA. attachment to the ASA. The documents are generally consistent, and any differences between the relevant sections are typically due to the different layouts of the documents. It is recommended that A table comparing the The sponsor’s response the sponsor outlines the US monograph, the has been noted. wording, by which proposed Australian PI important safety and the proposed EU concerns are addressed SmPC is provided as an in the US monograph attachment to the compared to the Australian-Specific proposed Australian PI, Annex. The documents and material differences are generally consistent, in the Australian PI and any differences should be justified. between the relevant sections are typically due to the different layouts of the documents. The following is brought Merck proposes to It appears that the to the delegate’s inform prescribers that writing in bold was attention. The following atypical responses can initially included in the statement is included in occur to Keytruda, and US prescribing the Australian PI in that prescribers should information, but was section and confirm progression in subsequently removed, ‘dosage administration’: The patients who are and more detailed recommended dose of clinically stable so that information was Keytruda is 2 mg/kg they do not prematurely included in the clinical administered discontinue treatment. trial section. This is in intravenously over 30 In P001, patients were line with the minutes every 3 weeks. allowed to remain on recommendations made
(Summary of Safety Concerns and Risk Minimization Activities) to describe only activities but not pharmacovigilance activities. Risk Minimization Measures’, Table 73 ‘Summary of Safety Concerns and Risk Minimization Activities’ of the EU-RMP has been modified and includes the routine risk minimization activities for each listed safety concern. RMP was provided with the response. It is recommended that the sponsor provides the updated RMP for review to approval. A table comparing the wording in the Australian-PI with the EU-SmPC should be provided as annex to the ASA. A table comparing the proposed EU SmPC, US monograph and the proposed Australian PI is provided as an attachment to the ASA. The documents are generally consistent, and any differences between the relevant sections are typically due to the different layouts of the documents. The has been provided by the sponsor. This is considered acceptable. It is recommended that the sponsor outlines the wording, by which important safety concerns are addressed in the US monograph compared to the proposed Australian PI, and material differences in the Australian PI should be justified. A table comparing the US monograph, the proposed Australian PI and the proposed EU SmPC is provided as an attachment to the Australian-Specific Annex. The documents are generally consistent, and any differences between the relevant sections are typically due to the different layouts of the documents. The sponsor’s response has been noted. The following is brought to the delegate’s attention. The following statement is included in the Australian PI in section ‘dosage and administration’: The recommended dose of Keytruda is 2 mg/kg administered intravenously over 30 minutes every 3 weeks. Merck proposes to inform prescribers that atypical responses can occur to Keytruda, and that prescribers should confirm progression in patients who are clinically stable so that they do not prematurely discontinue treatment. In P001, patients were allowed to remain on It appears that the writing in bold was initially included in the US prescribing information, but was subsequently removed, and more detailed information was included in the clinical trial section. This is in line with the recommendations made trial
auspar-pembrolizumab-rch-161014.docx