Imjudo
Registration timeline
The following table summarises the key steps and dates for this application.
|
Description |
Date |
|---|---|
|
Submission dossier accepted and first round evaluation commenced |
31 May 2022 |
|
First round evaluation completed |
22 November 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
23 December 2022 |
|
Second round evaluation completed |
15 February 2023 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
27 February 2023 |
|
Sponsor’s pre-Advisory Committee response |
13 March 2023 |
|
Advisory Committee meeting |
30 and 31 March 2023 |
|
Registration decision (Outcome) |
19 June 2023 |
|
Completion of administrative activities and registration on ARTG |
23 June 2023 |
|
Number of working days from submission dossier acceptance to registration decision* |
219 |
*Statutory timeframe for standard applications is 255 working days.
Disodium edetate, histidine, histidine hydrochloride monohydrate, polysorbate 80, trehalose dihydrate, water for injections.
The recommended dosage is 300 mg as a single priming dose in combination with durvalumab 1500 mg at Cycle 1/Day 1, followed by durvalumab monotherapy every 4 weeks until disease progression or unacceptable toxicity. Patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to Imjudo 4 mg/kg and durvalumab 20 mg/kg until weight is greater than 30 kg. Administer Imjudo prior to durvalumab on the same day. Imjudo is administered as an intravenous infusion over one hour and for single use in one patient only. Discard any residue.
The proposed combination should be administered and monitored under the supervision of physicians experienced with the use of immunotherapy.
For further information refer to the Product Information.
Drugs 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.
Imjudo (tremelimumab) was approved for the following therapeutic use:
Hepatocellular Carcinoma (HCC)
Imjudo in combination with durvalumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior treatment with a PD-1/PD-L1 inhibitor.
Tremelimumab is a selective, fully human immunoglobulin G (IgG)2 antibody that blocks CTLA 4 interaction with CD80 and CD86, thus enhancing T-lymphocyte activation and proliferation, resulting in increased T-lymphocyte diversity and enhanced antitumour immune activity. In syngeneic mouse tumour models, blocking CTLA-4 activity resulted in decreased tumour growth and increased proliferation of T-lymphocytes in tumours. The combination of durvalumab, a programmed death-ligand (PD-L)1 inhibitor, and tremelimumab functions to enhance anti-tumour T-lymphocyte activation and functions at multiple stages of the immune response, maximizing anti-tumour immunity.
- Imjudo (tremelimumab) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Imjudo 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 Imjudo EU [European Union]-Risk management plan (RMP) (version 2.0 succession 4.0, dated 27 December 2022, data lock point 27 August 2021), with Australian specific annex (version 1.0 succession 3.0, dated 16 March 2023), included with Submission PM‑2022-01514-1-4, 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.
- It is a condition of registration that all batches of Imjudo tremelimumab imported into/manufactured in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
Laboratory testing & compliance with Certified Product Details (CPD)
i. All batches of Imjudo tremelimumab supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
ii. 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 http://www.tga.gov.au/ws-labs-index and periodically in testing reports on the TGA website.
Further information
The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at the Australian Register of Therapeutic Goods (ARTG) search page.
Australian Public Assessment Reports (AusPARs) can be found at the AusPAR search page.
The latest news and updates regarding therapeutic goods regulation can be found at the TGA news page.