Truseltiq
Registration timeline
The following table summarises the key steps and dates for this application.
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) 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 |
|---|---|
| Designation (Orphan and Provisional) | 30 October 2020 |
| Submission dossier accepted and first round evaluation commenced | 4 January 2021 |
| First round evaluation completed | 3 June 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 2 July 2021 |
| Second round evaluation completed | 24 August 2021 |
| Delegate's overall benefit-risk assessment | 6 October 2021 |
| Sponsor's pre-Advisory Committee response | Not Applicable |
| Advisory Committee meeting | Not Applicable |
| Registration decision (Outcome) | 2 November 2021 |
| Completion of administrative activities and registration on ARTG | 5 November 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 189 |
*Statutory timeframe for standard applications is 255 working days
The recommended dose of Truseltiq is 125 mg (one 100 mg hard capsule and one 25 mg hard capsule) orally once daily for 21 consecutive days followed by 7 days off therapy, in 28 day cycles. Continue treatment until disease progression or unacceptable toxicity.
For further information refer to the Product Information.
Truseltiq (infigratinib) was approved for the following therapeutic use:
Truseltiq infigratinib has provisional approval in Australia for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement (see Section 4.2 Dose and method of administration). The decision to approve this indication has been made on the basis of overall response rate and duration of response in a single arm trial. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
- Truseltiq (infigratinib) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Truseltiq must include the black triangle symbol and mandatory accompanying text for the product’s entire period of provisional registration.
- Periodic safety update reports and risk management plan conditions.
Medicines with a risk management plan
The infigratinib core-risk management plan (RMP) (version 1.0, dated 20 September2021, data lock point 1 March 2021) with Australian specific annex (version 1.2, dated 21 September 2021), included with Submission PM-2020-06031-1-4, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of RMP 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, or the entire period of provisional registration, whichever is longer.
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.
- 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 6 years that would start on the day that registration would commence) must be provided.
Specifically, the sponsor must conduct studies as described in the clinical study plan in version 1.0 (dated 23 June 2021) of the Australia specific annex. The following study report(s) should be submitted to the TGA:
- Study CBGJ398X2204, ClinicalTrials.gov identifier NCT02150967, by the second quarter in 2023
- Study QBGJ398-301, the PROOF trial, by the second quarter in 2027.
Further guidance for sponsors is available on the TGA website.