Table 5. Reconciliation of issues outlined in the RMP report Recommendation in RMP Sponsor’s response RMP report evaluator’s comment 1. Safety considerations may be The sponsor acknowledges that further change to This is raised by the clinical evaluators the RMP may be requested and commits to considered through TGA requests and/or responding to these as they occur. acceptable in the Clinical Evaluation Report. the context of It is important to ensure that this the information provided in application response to these includes a for RMP consideration of the relevance purposes. for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, please provide information that is relevant and necessary to address the issue in the RMP. 2-3. Administrative questions An updated ASA was included as requested This is and recommendations. considered acceptable in the context of this application for RMP purposes. 4. The sponsor should provide An update on the requested studies was provided. The sponsor’s an update on Studies response has NCT01780662, C25003, been noted. SGN35-011, SGN35-014, and X25001 with regard to interactions with other anticancer agents. 5. The sponsor should provide a Background: Overdose is the administration of a The sponsor’s summary of the post-market quantity of a medicinal product given per response has experience with overdose. administration or day that is above the maximal been noted. recommended dose according to the authorised PI. Overdose can be accidental, prescribed or intentional, with clear labelling guidelines a key in minimising medication errors. Depending on the therapeutic index of the drug and the dose given to the patient, an adverse drug reaction may or may not be the outcome of an overdose. A post-market analysis of the Global Safety Database (GSDB) for brentuximab vedotin was performed to provide a summary of the post-marketing experience with overdose and to determine if there is an association of overdose and adverse events. Methodology: The Marketing Authorisation Holder (MAH) performed a cumulative review of the GSDB with a data lock of 15 January 2016 for all cases from post-marketing sources (literature, spontaneous, post-marketing surveys and regulatory authorities’ reports) that met an Overdose specialized search query criteria, which encompasses the following 4 preferred terms: High
Table 5. Reconciliation of issues outlined in the RMP report Recommendation in RMP report Sponsor’s response RMP evaluator’s comment 1. Safety considerations may be raised by the clinical evaluators through TGA requests and/or the Clinical Evaluation Report. It is important to ensure that the information provided in response to these includes 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, please provide information that is relevant and necessary to address the issue in the RMP. The sponsor acknowledges that further change to the RMP may be requested and commits to responding to these as they occur. This is considered acceptable in the context of this application for RMP purposes. 2-3. Administrative questions and recommendations. An updated ASA was included as requested This is considered acceptable in the context of this application for RMP purposes. 4. The sponsor should provide an update on Studies NCT01780662, C25003, SGN35-011, SGN35-014, and X25001 with regard to interactions with other anticancer agents. An update on the requested studies was provided. The sponsor’s response has been noted. 5. The sponsor should provide a summary of the post-market experience with overdose. Background: Overdose is the administration of a quantity of a medicinal product given per administration or day that is above the maximal recommended dose according to the authorised PI. Overdose can be accidental, prescribed or intentional, with clear labelling guidelines a key in minimising medication errors. Depending on the therapeutic index of the drug and the dose given to the patient, an adverse drug reaction may or may not be the outcome of an overdose. A post-market analysis of the Global Safety Database (GSDB) for brentuximab vedotin was performed to provide a summary of the post-marketing experience with overdose and to determine if there is an association of overdose and adverse events. Methodology: The Marketing Authorisation Holder (MAH) performed a cumulative review of the GSDB with a data lock of 15 January 2016 for all cases from post-marketing sources (literature, spontaneous, post-marketing surveys and regulatory authorities’ reports) that met an Overdose specialized search query criteria, which encompasses the following 4 preferred terms: High The sponsor’s response has been noted.
auspar-brentuximab-vedotin-170914.docx