The following table summarises the key steps and dates for this application.
|Determination (Provisional)||15 September 2020|
|Submission dossier accepted and first round evaluation commenced||1 February 2021|
|First round evaluation completed||30 June 2021|
|Sponsor provides responses on questions raised in first round evaluation||31 August 2021|
|Second round evaluation completed||6 October 2021|
|Delegate's overall benefit-risk assessment||6 January 2022|
|Sponsor's pre-Advisory Committee response||Not applicable|
|Advisory Committee meeting||Not applicable|
|Registration decision (Outcome)||15 February 2022|
|Completion of administrative activities and registration on ARTG||17 February 2022|
|Number of working days from submission dossier acceptance to registration decision*||208|
*Statutory timeframe for standard applications is 255 working days
The recommended dose as monotherapy is 500 mg dostarlimab administered as an intravenous infusion over 30 minutes every 3 weeks for 4 doses followed by 1,000 mg every 6 weeks for all cycles thereafter.
For further information refer to the Product Information.
Jemperli (dostarlimab) was approved for the following therapeutic use:
Jemperli is indicated as monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.
This medicine and indication have provisional approval, based on objective response rate and duration of response in a single-arm trial. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.
- Jemperli (dostarlimab) is to be included in the Black Triangle Scheme. The [Product Information] PI and [Consumer Medicines Information] CMI for Jemperli must include the black triangle symbol and mandatory accompanying text for the products entire period of provisional registration.
- The Jemperli [European Union] EU-risk management plan (RMP) (version 1.1, dated 12 April 2021, data lock point 1 March 2020), with Australian specific annex (version 3.0 dated October 2021), included with Submission PM 2020 06455 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, 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 ([revision] 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 and compliance with Certified Product Details (CPD)
- All batches of Jemperli dostarlimab 500 mg solution for infusion 10 mL vial supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in 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 [portable document format] 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.
The CPD should be emailed as a single PDF document.
- 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 3.0 (dated October 2021) of the Australia specific annex. The following study reports should be submitted to TGA:
- Study 4010 01 001 [the GARNET trial] by date 14 January 2028, and
- Study 4010 03 001 [the RUBY trial] by date 14 January 2028
Further guidance for sponsors is available on the TGA website.
- For all injectable products the Product Information must be included with the product as a package insert.