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Kimmtrak
Update: the current sponsor for Kimmtrak is Medison Pharma Australia Pty Ltd. See the latest Australian Register of Therapeutic Goods (ARTG) information for Kimmtrak.
Sponsor
Device/Product name
Kimmtrak
Active Ingredient
Tebentafusp
Date of decision
Published
Submission type
New biological entity
ATC codes
Not yet assigned
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Kimmtrak was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
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) 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 Priority |
30 August 2021 30 August 2021 |
| Submission dossier accepted and first round evaluation commenced | 26 October 2021 |
| First round evaluation completed | 1 March 2022 |
| Sponsor provides responses on questions raised in first round evaluation | 1 March 2022 |
| Second round evaluation completed | 10 March 2022 |
| Delegate's overall benefit-risk assessment | 19 April 2022 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 27 May 2022 |
| Completion of administrative activities and registration on ARTG | 3 June 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 120 |
*Target timeframe for priority applications is 150 working days from acceptance for evaluation to the decision
Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Dose forms
Concentrated solution for infusion
Strength
0.1 mg/0.5 mL
Other ingredients
Citric acid monohydrate, dibasic sodium phosphate, mannitol, trehalose dihydrate, polysorbate 20 and water for injections
Containers
Vial
Pack sizes
One
Routes of administration
Intravenous infusion
Dosage
Kimmtrak should be administered under the supervision of a physician experienced in the use of anti-cancer agents.
The recommended dose of Kimmtrak is:
- 20 micrograms on Day 1
- 30 micrograms on Day 8
- 68 micrograms on Day 15
- 68 micrograms once every week thereafter
Continue treatment with Kimmtrak until disease progression or unacceptable toxicity occurs.
For further information refer to the Product Information.
Pregnancy category
C
Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.
Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.
What was approved
Kimmtrak (tebentafusp) was approved for the following therapeutic use:
Kimmtrak is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
What is this medicine and how does it work
Tebentafusp is a bispecific fusion protein, comprised of a T cell (T lymphocyte) receptor (TCR) fused to an antibody fragment with specificity for the CD3 (cluster of differentiation 3) receptor, found on polyclonal T cells. The TCR has specificity for a glycoprotein 100 (gp100) peptide (expressed preferentially in melanoma cells) presented by human leukocyte antigen A (HLA)*02:01.
In vitro, tebentafusp bound to HLA-A*02:01-positive uveal melanoma cells and activated polyclonal T cells to release inflammatory cytokines and cytolytic proteins, which results in direct lysis of uveal melanoma tumour cells.
In vitro, tebentafusp bound to HLA-A*02:01-positive uveal melanoma cells and activated polyclonal T cells to release inflammatory cytokines and cytolytic proteins, which results in direct lysis of uveal melanoma tumour cells.
What post-market commitments will the sponsor undertake
- Kimmtrak (tebentafusp) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Kimmtrak 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 Kimmtrak European Union (EU)-risk management plan (RMP) (version 0.3, dated 28 Jan 2022, data lock point 13 October 2020), with Australian specific annex (version 0.2, dated 15 February 2022), included with Submission PM 2021 04357 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).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs 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 (revision 1), Part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
- For all injectable products the Product Information must be included with the product as a package insert.