Brukinsa
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Designation (Provisional) | 17 June 2020 |
| Submission dossier accepted and first round evaluation commenced | 31 July 2020 |
| First round evaluation completed | 24 December 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 1 March 2021 |
| Second round evaluation completed | 15 April 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 5 July 2021 |
| Sponsor's pre-Advisory Committee response | 14 July 2021 |
| Advisory Committee meeting | 5 and 6 August 2021 |
| Registration decision (Outcome) | 8 October 2021 |
| Completion of administrative activities and registration on ARTG | 8 October 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 250 |
*Statutory timeframe for standard applications is 255 working days
The recommended total daily oral dose of zanubrutinib is 320 mg. Zanubrutinib may be taken as either 320 mg (four 80 mg capsules) once daily, or as 160 mg (two 80 mg capsules) twice daily.
For further information refer to the Product Information.
Brukinsa (zanubrutinib) was approved for the following therapeutic use:
Mantle cell lymphoma (MCL)
Brukinsa is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
This indication was approved via the provisional approval pathway, based on objective response rate. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.
- Brukinsa (zanubrutinib) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Brukinsa must include the black triangle symbol and mandatory accompanying text for the products entire period of provisional registration.
- The Brukinsa European Union (EU) risk management plan (RMP) (version 0.1, dated 11 May 2020, data lock point 31 Dec 2019), with Australian specific annex (ASA) (version 0.1, dated 1 June 2020), included with Submission PM-2020-02814-1-6, to be revised to the satisfaction of the TGA, will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on Good Pharmacovigilance Practices (GVP) Module VII-Periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
- The sponsor must provide confirmatory trial data (as identified in the sponsor's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the six years that would start on the day that registration would commence).
Specifically, the sponsor must conduct studies as described in the clinical study plan in Version 1.0 (1 June 2020) of the ASA. The following study report(s) should be submitted to TGA:
- Study BGB-3111-306 by October 2023 (first interim analysis), June 2025 (second interim analysis), September 2027 (final analysis).
- The sponsor to provide the final clinical study report for Study BGB-3111-206 for evaluation.