risk, the Company has added precautionary language in the Warning and Precautions section of the prescribing information as described below. lysis syndrome “Tumour Tumour syndrome has been reported with IMBRUVICA therapy. Patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment. Monitor patients closely and take appropriate precautions.” Tumour lysis syndrome is an important potential risk described in the EU Risk Management Plan and was also included in the Australian Specific Annex (ASA). The Company will continue to routinely monitor reports of tumour lysis syndrome in association with the use of ibrutinib. A full review of all reports of tumour lysis cases from worldwide clinical trials and post marketing sources is provided. To date, are no other new safety signals that have been identified from post-marketing surveillance. Evaluator comment: This PI entry is satisfactory matters The sponsor has amended the indication of Ibrutinib in Section 31 response, as proposed by the clinical evaluator in the Round 1 Evaluation, to: Chronic Lymphocytic Leukaemia/Small Lymphocytic Leukaemia (CLL/SLL) IMBRUVICA is indicated for the treatment of patients with CLL/SLL: Who have received at least one prior therapy Or for the frontline treatment of patients with CLL with 17p deletion The amended indication is in line with that approved in the USA, EU and Canada. The proposed amended indication is still supported by the clinical evaluator. Second benefit-risk assessment Second round assessment of benefits The benefits from ibrutinib remain the same as at the first round evaluation. Second round assessment of risks The risks of ibrutinib therapy now include an observed risk of tumour lysis syndrome. This AE is expected in the clinical context, and is appropriately warned for. The clinical management of patients anticipated to experience tumour lysis is a standard of care in oncology patients. This additional risk does not outweigh the benefits of ibrutinib. Second round assessment of benefit-risk balance The benefit-risk balance of ibrutinib, given the proposed usage in both CLL/SLL and MCL populations is favourable.
risk, the Company has added precautionary language in the Warning and Precautions section of the prescribing information as described below. “Tumour lysis syndrome Tumour syndrome has been reported with IMBRUVICA therapy. Patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment. Monitor patients closely and take appropriate precautions.” Tumour lysis syndrome is an important potential risk described in the EU Risk Management Plan and was also included in the Australian Specific Annex (ASA). The Company will continue to routinely monitor reports of tumour lysis syndrome in association with the use of ibrutinib. A full review of all reports of tumour lysis cases from worldwide clinical trials and post marketing sources is provided. To date, are no other new safety signals that have been identified from post-marketing surveillance. Evaluator comment: This PI entry is satisfactory matters The sponsor has amended the indication of Ibrutinib in Section 31 response, as proposed by the clinical evaluator in the Round 1 Evaluation, to: Chronic Lymphocytic Leukaemia/Small Lymphocytic Leukaemia (CLL/SLL) IMBRUVICA is indicated for the treatment of patients with CLL/SLL: Who have received at least one prior therapy Or for the frontline treatment of patients with CLL with 17p deletion The amended indication is in line with that approved in the USA, EU and Canada. The proposed amended indication is still supported by the clinical evaluator. Second benefit-risk assessment Second round assessment of benefits The benefits from ibrutinib remain the same as at the first round evaluation. Second round assessment of risks The risks of ibrutinib therapy now include an observed risk of tumour lysis syndrome. This AE is expected in the clinical context, and is appropriately warned for. The clinical management of patients anticipated to experience tumour lysis is a standard of care in oncology patients. This additional risk does not outweigh the benefits of ibrutinib. Second round assessment of benefit-risk balance The benefit-risk balance of ibrutinib, given the proposed usage in both CLL/SLL and MCL populations is favourable.
auspar-ibrutinib-160202-cer.docx