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 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).
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||24 February 2021|
|Evaluation completed||21 July 2021|
|Delegate's overall benefit-risk assessment||31 August 2021|
|Sponsor's pre-Advisory Committee response||Not applicable|
|Advisory Committee meeting||Not applicable|
|Registration decision (Outcome)||3 September 2021|
|Completion of administrative activities and registration on ARTG||6 September 2021|
|Number of working days from submission dossier acceptance to registration decision*||111|
*Target timeframe for priority applications is 150 working days from acceptance for evaluation to the decision.
The recommended dose of Trodelvy is 10 mg/kg administered as an intravenous (IV) infusion once weekly on Days 1 and 8 of 21-day treatment cycles. The required dose (mg) of Trodelvy is calculated based on the patient’s body weight at the beginning of each treatment cycle.
For further information refer to the Product Information.
Trodelvy (sacituzumab govitecan) was approved for the following therapeutic use:
Trodelvy is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies, including at least one prior therapy for locally advanced or metastatic disease.
- Trodelvy (sacituzumab govitecan) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Trodelvy 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 Trodelvy European Union (EU)-Risk Management Plan (RMP) (version 0.1, dated 16 February 2021, data lock point 18 September 2020), with Australian specific annex (version 0.2, dated 18 June 2021), included with submission PM-2021-00038-1-4, 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.
- Laboratory testing & compliance with Certified Product Details
- All batches of Trodelvy supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.
Certified Product Details
The Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- A report that evaluates the impact of immunogenicity on pharmacokinetics, efficacy and safety of sacituzumab govetican in patients will be submitted when available (expected availability in 2023).
- For all injectable products the Product Information must be included with the product as a package insert.