generally manageable and well within the province of oncologists areas of expertise. Accordingly the evaluator considers the benefit-risk balance favourable. List of questions None Recommendation regarding authorisation The evaluator considers that on balance and in view of the discussion indicated above there is evidence of definite efficacy for romidepsin in the treatment of advanced stage relapsed and refractory PTCL. Despite the fact that the studies involved were Phase II in nature without a direct comparator, the evaluator considers that the overall evidence of benefit versus the relative risks involved would support approval for marketing of this agent. It is also worth commenting that approval for romidepsin in the management of patients with advanced stage refractory and relapsed PTCL has been given by the US FDA. V. Pharmacovigilance findings Risk management plan The sponsor submitted a Risk Management Plan (EU-RMP Version 3.0 (dated 05/05/2012, DLP 31/10/2010), and Australian Specific Annex Version 1.0 (dated 08/06/2012)) which was reviewed by the TGA’s Office of Product Review (OPR). Safety specification Subject to the evaluation of the nonclinical aspects of the Safety Specification (SS) by the Toxicology area of the TGA Office of Scientific Evaluation and the clinical aspects of the SS by the Office of Medicines Authorisation, the summary of the Ongoing Safety Concerns as specified by the sponsor is as follows (Table 10): Table 10. Important identified and potential risks and missing information. OPR reviewer comment: Notwithstanding the evaluation of the non-clinical and clinical aspects of the SS, this is considered acceptable. Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities for important identified and potential and missing information (as stated above). Furthermore, additional activities are planned for some risks: clinical trials are planned to further study potential drug interactions and the risk in patients with impaired hepatic function, and a drug utilisation study in Europe is planned to study the risks in off-label use. Risk minimisation activities No additional risk minimisation activities are proposed for Istodax.
generally manageable and well within the province of oncologists areas of expertise. Accordingly the evaluator considers the benefit-risk balance favourable. List of questions None Recommendation regarding authorisation The evaluator considers that on balance and in view of the discussion indicated above there is evidence of definite efficacy for romidepsin in the treatment of advanced stage relapsed and refractory PTCL. Despite the fact that the studies involved were Phase II in nature without a direct comparator, the evaluator considers that the overall evidence of benefit versus the relative risks involved would support approval for marketing of this agent. It is also worth commenting that approval for romidepsin in the management of patients with advanced stage refractory and relapsed PTCL has been given by the US FDA. V. Pharmacovigilance findings Risk management plan The sponsor submitted a Risk Management Plan (EU-RMP Version 3.0 (dated 05/05/2012, DLP 31/10/2010), and Australian Specific Annex Version 1.0 (dated 08/06/2012)) which was reviewed by the TGA’s Office of Product Review (OPR). Safety specification Subject to the evaluation of the nonclinical aspects of the Safety Specification (SS) by the Toxicology area of the TGA Office of Scientific Evaluation and the clinical aspects of the SS by the Office of Medicines Authorisation, the summary of the Ongoing Safety Concerns as specified by the sponsor is as follows (Table 10): Table 10. Important identified and potential risks and missing information. OPR reviewer comment: Notwithstanding the evaluation of the non-clinical and clinical aspects of the SS, this is considered acceptable. Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities for important identified and potential and missing information (as stated above). Furthermore, additional activities are planned for some risks: clinical trials are planned to further study potential drug interactions and the risk in patients with impaired hepatic function, and a drug utilisation study in Europe is planned to study the risks in off-label use. Risk minimisation activities No additional risk minimisation activities are proposed for Istodax.
auspar-romidepsin-131120.docx