The sponsor should provide information on the post market experience of patients with central nervous system conditions that are taking enzalutamide. Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities for important identified and potential risks and missing information. Furthermore, additional activities are planned for some of the risks. These activities are summarised in Table 18. 18: Additional pharmacovigilance activities planned by the sponsor. Additional Assigned Actions/outcome Estimated activity safety proposed planned concern submission of final data Post Seizure The safety of Study completion authorisation enzalutamide in date: June 2018 safety study patients excluded from Final report the pivotal study due to Category: 3 submission: March certain baseline factors Ongoing 2019 considered predisposing for seizure. Clinical study Patients with Assess, in subjects with Study completion Category: 3 moderate or normal hepatic function date: May 2014 severe hepatic and patients with Ongoing at Final report impairment severe hepatic time of RMP submission: (study impairment, the effect sign-off date. November 2014 concerned of severe hepatic with severe impairment on the hepatic pharmacokinetics of impairment) enzalutamide and enzalutamide Clinical study Patients with Assess, in subjects with Draft protocol Category: 3 moderate or normal hepatic function submission: severe hepatic and patients with February 2014 Planned at impairment moderate time of RMP Final report hepatic impairment, the sign-off date; submission: effect of moderate now ongoing concerned December 2015 hepatic impairment on with moderate the pharmacokinetics of hepatic enzalutamide and impairment) enzalutamide Post- Data on the Data on the efficacy of Report of interim authorisation efficacy of enzalutamide in Analysis: June 2015 efficacy study enzalutamide patients with metastatic Final report Category: 3 in patients CRPC previously submission: with Ongoing December 2016 metastatic
The sponsor should provide information on the post market experience of patients with central nervous system conditions that are taking enzalutamide. Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities for important identified and potential risks and missing information. Furthermore, additional activities are planned for some of the risks. These activities are summarised in Table 18. 18: Additional pharmacovigilance activities planned by the sponsor. Additional activity Assigned safety concern Actions/outcome proposed Estimated planned submission of final data Post authorisation safety study Category: 3 Ongoing Seizure The safety of enzalutamide in patients excluded from the pivotal study due to certain baseline factors considered predisposing for seizure. Study completion date: June 2018 Final report submission: March 2019 Clinical study Category: 3 Ongoing at time of RMP sign-off date. Patients with moderate or severe hepatic impairment (study concerned with severe hepatic impairment) Assess, in subjects with normal hepatic function and patients with severe hepatic impairment, the effect of severe hepatic impairment on the pharmacokinetics of enzalutamide and enzalutamide Study completion date: May 2014 Final report submission: November 2014 Clinical study Category: 3 Planned at time of RMP sign-off date; now ongoing Patients with moderate or severe hepatic impairment concerned with moderate hepatic impairment) Assess, in subjects with normal hepatic function and patients with moderate hepatic impairment, the effect of moderate hepatic impairment on the pharmacokinetics of enzalutamide and enzalutamide Draft protocol submission: February 2014 Final report submission: December 2015 Post- authorisation efficacy study Category: 3 Ongoing Data on the efficacy of enzalutamide in patients with metastatic Data on the efficacy of enzalutamide in patients with metastatic CRPC previously Report of interim Analysis: June 2015 Final report submission: December 2016
auspar-enzalutamide-160323.docx