OPR reviewer comment: Notwithstanding the evaluation of the nonclinical and clinical aspects of the SS, this was considered acceptable. Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities for important identified and potential risks and missing information (as stated above). Furthermore, additional activities are planned for some of the risks. These activities are summarised in Table 8. Table 8. Activities additional to routine planned by the sponsor regarding certain safety concerns. Table continued across2 pages. Additional Assigned Actions/outcome proposed Planned activity safety submission concern of final data Trial Cardiac Primary Objective: 2013 (QTc) disorders To evaluate the effects of A QT/QTc and abiraterone acetate plus multi-dose PK prednisone on cardiac QT/QTc Study of interval by using Abiraterone pharmacokinetic and Acetate ECGs in patients with (CB7630) Plus metastatic castration resistant Prednisone in prostate cancer (CRPC) Patients with Secondary Objectives: Metastatic Castration- To evaluate the Resistant pharmacokinetics (PK) of Prostate Cancer abiraterone acetate and abiraterone after multiple doses Protocol of abiraterone acetate available To evaluate the effects of abiraterone acetate and prednisone To evaluate the effects of abiraterone acetate and prednisone on adrenal function as measured by the Cortrosyn stimulation test at baseline and after abiraterone acetate/prednisone administration Targeted Hepatotoxicity follow-up with Osteoporosis reporter including through a guided fractures questionnaire
OPR reviewer comment: Notwithstanding the evaluation of the nonclinical and clinical aspects of the SS, this was considered acceptable. Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities for important identified and potential risks and missing information (as stated above). Furthermore, additional activities are planned for some of the risks. These activities are summarised in Table 8. Table 8. Activities additional to routine planned by the sponsor regarding certain safety concerns. Table continued across2 pages. Additional activity Assigned safety concern Actions/outcome proposed Planned submission of final data Trial (QTc) A QT/QTc and multi-dose PK Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic Castration- Resistant Prostate Cancer Protocol available Cardiac disorders Primary Objective: To evaluate the effects of abiraterone acetate plus prednisone on cardiac QT/QTc interval by using pharmacokinetic and ECGs in patients with metastatic castration resistant prostate cancer (CRPC) Secondary Objectives: To evaluate the pharmacokinetics (PK) of abiraterone acetate and abiraterone after multiple doses of abiraterone acetate To evaluate the effects of abiraterone acetate and prednisone To evaluate the effects of abiraterone acetate and prednisone on adrenal function as measured by the Cortrosyn stimulation test at baseline and after abiraterone acetate/prednisone administration 2013 Targeted follow-up with reporter through a guided questionnaire Hepatotoxicity Osteoporosis including fractures
auspar-abiraterone-acetate-140122.docx