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The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.
Australian prescription medicine decision summary
|Submission type|| |
New chemical entity
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
|Date of decision|| |
7 October 2021
|Date of entry onto ARTG|| |
7 October 2021
|Original publication date|| |
20 October 2021
|ARTG numbers|| |
|Black Triangle Scheme|| |
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
BeiGene AUS Pty Ltd
|Sponsor address|| |
1C/528 Compton Road, Stretton QLD 4116
|Dose forms|| |
|Other ingredients|| |
Microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide, Opacode monogramming ink S-1-277002 black
|Pack sizes|| |
|Routes of administration|| |
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.
|Pregnancy category|| |
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
Brukinsa (zanubrutinib) was approved for the following therapeutic use:
Waldenström’s macroglobulinemia (WM)Brukinsa is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
Zanubrutinib is a small molecule inhibitor of Bruton's tyrosine kinase (BTK). Zanubrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK activity. BTK is a signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, zanubrutinib inhibited malignant B-cell proliferation and reduced tumour growth.
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Brukinsa was considered favourable for the therapeutic use approved.
The following table summarises the key steps and dates for this application.
|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||26 February 2021|
|Second round evaluation completed||15 April 2021|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||6 July 2021|
|Sponsor's pre-Advisory Committee response||14 July 2021|
|Advisory Committee meeting||5 and 6 August 2021|
|Registration decision (Outcome)||7 October 2021|
|Completion of administrative activities and registration on ARTG||7 October 2021|
|Number of working days from submission dossier acceptance to registration decision*||240|
*Statutory timeframe for standard applications is 255 working days
- 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 five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Brukinsa European Union (EU) Risk Management Plan (RMP) (version 0.1, dated 11 May 2020, data lock point 31 December 2019), with Australian Specific Annex (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 to provide the final study report of Study BGB-3111-206 for evaluation.