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328525, 328526
328525, 328526
Device/Product name
Active Ingredient
Date of decision
Submission type
New chemical entity
ATC codes
What was the decision based on
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 Tukysa was considered favourable for the therapeutic use approved.
What steps were involved in the decision process

Registration timeline

The following table summarises the key steps and dates for this application, evaluated through Priority Review.

This evaluation was facilitated through Project Orbis, an initiative of the United States (US) Food and Drug Administration (FDA) Oncology Center of Excellence (OCE). Under this project, the FDA, Health Canada (HC), Health Sciences Authority (HSA, Singapore), Swissmedic (SMC, Switzerland) and the TGA collaboratively reviewed the application. This innovative evaluation process provided a framework for process alignment and management of evaluation issues in real-time across jurisdictions.

Each regulator agency maintained its regulatory process to make independent decisions about the approval (market authorisation).

Description Date
Submission dossier accepted and first round evaluation commenced 2 March 2020
Evaluation completed 29 June 2020
Delegate's overall benefit-risk assessment 27 July 2020
Sponsor's pre-Advisory Committee response Not applicable
Advisory Committee meeting Not applicable
Registration decision (Outcome) 10 August 2020
Completion of administrative activities and registration on ARTG 13 August 2020
Number of working days from submission dossier acceptance to registration decision* 113

*Target timeframe for priority applications is 150 working days from acceptance for evaluation to the decision.

Date of entry onto ARTG
Original publication date
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
Dose forms
Film coated tablet
50 mg, 150 mg
Other ingredients
Copovidone, crospovidone, sodium chloride, potassium chloride, sodium bicarbonate, silicon dioxide, magnesium stearate, microcrystalline cellulose, Opadry II Yellow 85F9272
Blister pack
Pack sizes
88 tablets (50 mg), 84 tablets (150 mg)
Routes of administration

Tukysa treatment should be initiated and supervised by a physician experienced in the administration of anti-cancer medicinal products.

The recommended dose of Tukysa is 300 mg taken orally twice daily in combination with trastuzumab and capecitabine until disease progression or unacceptable toxicity.

For further information refer to the Product Information.

Pregnancy category
DDrugs 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.
What was approved

Tukysa (tucatinib) was approved for the following therapeutic use:

Tukysa is indicated in combination with trastuzumab and capecitabine for treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
What is this medicine and how does it work
Tucatinib is a tyrosine kinase inhibitor of human epidermal growth factor receptor 2 (HER2). In vitro, tucatinib inhibits phosphorylation of HER2 and human epidermal growth factor receptor 3 (HER3), resulting in inhibition of downstream mitogen-activated protein kinase (MAPK) and AKT signalling and cell proliferation, and showed anti-tumour activity in HER2-expressing tumour cells. In vivo, tucatinib inhibited the growth of HER2-expressing tumours. The combination of tucatinib and trastuzumab showed increased anti-tumour activity in vitro and in vivo compared to either drug alone.
What post-market commitments will the sponsor undertake
  • Tukysa (tucatinib) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Tukysa 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 Tukysa European Union-Risk Management Plan (EU-RMP) (version 0.1, dated 20 December 2019; data lock point (DLP) 4 September 2019), with Australian specific Annex (version 0.2, dated May 2020), included with submission PM-2020-00066-1-4, and any subsequent revisions, as agreed with 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.

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