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).
|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.
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.
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.
- 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.