patients with relapsed or refractory CLL for whom there are no other suitable treatment options. Note to Indications. indications are approved based on overall response rates. Duration of response and improvements in overall survival, progression-free survival or health-related quality of life, have not been established. (Note the pluralisation of the to the indication’) ‘Note V. Pharmacovigilance findings Risk management plan Summary AbbVie Pty Ltd submitted EU-RMP version 1 (October 2015; DLP 30 2015) and ASA version 1 (January 2016) with the application to register venetoclax. An updated ASA (version 1.1, August 2016) was submitted with the sponsor’s response to questions. The sponsor later submitted EU-RMP version 2.0 (Date October 2016 data lock point (DLP) 30 April 201527) and ASA version 1.2 (October 2016). The proposed Summary of Safety Concerns and their associated risk monitoring and mitigation strategies are summarised below: Table 4: Summary of Safety concerns R=routine and A=additional Pharmacovigilance Risk Minimisation R A R A Important identified Tumour lysis syndrome * – – risks Neutropenia – – Important potential Embryofetal toxicity# – – risks Testicular toxicity** – – Medication Error**,# * – – Serious infection – – Richter’s – – transformation** DDI (CYP3A inducers, – – CYP3A inhibitors) Missing information Carcinogenicity – – Safety in severe hepatic – impairment Safety in severe renal – – impairment Safety in long-term – exposure (> 12 months) * = In response to TGA recommendations the sponsor has agreed to provide a patient alert card as part of their packaging in addition to their intended start guide’; ‘quick # = The sponsor has added these safety concerns in response to the first round RMP evaluation; ** = changed or added in the revised EU RMP version 2.0 (October 2016) and ASA version 1.2 (October 2016.
patients with relapsed or refractory CLL for whom there are no other suitable treatment options. Note to Indications. indications are approved based on overall response rates. Duration of response and improvements in overall survival, progression-free survival or health-related quality of life, have not been established. (Note the pluralisation of the ‘Note to the indication’) V. Pharmacovigilance findings Risk management plan Summary AbbVie Pty Ltd submitted EU-RMP version 1 (October 2015; DLP 30 2015) and ASA version 1 (January 2016) with the application to register venetoclax. An updated ASA (version 1.1, August 2016) was submitted with the sponsor’s response to questions. The sponsor later submitted EU-RMP version 2.0 (Date October 2016 data lock point (DLP) 30 April 201527) and ASA version 1.2 (October 2016). The proposed Summary of Safety Concerns and their associated risk monitoring and mitigation strategies are summarised below: Table 4: Summary of Safety concerns R=routine and A=additional Pharmacovigilance Risk Minimisation R A R A Important identified risks Tumour lysis syndrome – * – Neutropenia – – Important potential risks Embryofetal toxicity# – – Testicular toxicity** – – Medication Error**,# – * – Serious infection – – Richter’s transformation** – – DDI (CYP3A inducers, CYP3A inhibitors) – – Missing information Carcinogenicity – – Safety in severe hepatic impairment – Safety in severe renal impairment – – Safety in long-term exposure (> 12 months) – * = In response to TGA recommendations the sponsor has agreed to provide a patient alert card as part of their packaging in addition to their intended ‘quick start guide’; # = The sponsor has added these safety concerns in response to the first round RMP evaluation; ** = changed or added in the revised EU RMP version 2.0 (October 2016) and ASA version 1.2 (October 2016.