Tecvayli
Registration timeline
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, ANVISA (Brazil), Health Canada, Swissmedic 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 (Provisional) |
9 March 2022 |
|
Submission dossier accepted and first round evaluation commenced |
31 May 2022 |
|
First round evaluation completed |
21 November 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
23 January 2023 |
|
Second round evaluation completed |
15 February 2023 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
3 March 2023 |
|
Sponsor’s pre-Advisory Committee response |
16 March 2023 |
|
Advisory Committee meeting |
30 and 31 March 2023 |
|
Registration decision (Outcome) |
2 June 2023 |
|
Completion of administrative activities and registration on ARTG |
14 June 2023 |
|
Number of working days from submission dossier acceptance to registration decision* |
209 |
*Statutory timeframe for standard applications is 255 working days.
Disodium edetate, glacial acetic acid, polysorbate 20, sodium acetate trihydrate, sucrose and water for injections.
Treatment with Tecvayli should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. Tecvayli should be administered by subcutaneous injection only.
The recommended dosage of Tecvayli is step-up doses of 0.06 mg/kg and 0.3 mg/kg followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity.
For further information refer to the Product Information.
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.
Tecvayli (teclistamab) was approved for the following therapeutic use:
The provisionally approved new indication(s) for the medicine(s) are:
Tecvayli as monotherapy has provisional approval in Australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
The decision to approve this indication has been made on the basis of the overall response rate in a single arm study. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
- Tecvayli (teclistamab) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Tecvayli must include the black triangle symbol and mandatory accompanying text for five years, or the product’s entire period of provisional registration, whichever is longer.
- The Tecvayli EU [European Union]-risk management plan (RMP) (version 1.5, dated 26 August 2022, data lock point 16 March 2022), with Australia specific annex (version 3.0, dated 20 February 2023), included with Submission PM-2022-01541-1-6, 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 & compliance with Certified Product Details (CPD)
- All batches of Tecvayli (teclistamab) 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 http://www.tga.gov.au/ws-labs-index and periodically in testing reports on the TGA website.
- 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 template for preparation of CPD for biological prescription medicines can be obtained from the TGA website
[for the form] https://www.tga.gov.au/form/certified-product-details-cpd-biological-prescription-medicines
[for the CPD guidance] https://www.tga.gov.au/guidance-7-certified-product-details
- The sponsor must conduct studies as described in the clinical study plan in version 2.0 (dated 15 December 2022) of the Australia specific annex.
- Final study reports for the following studies should be submitted to TGA for evaluation:
- 64007957MMY3001 (MajesTEC-3)
- 64007957MMY1001 – Updated safety report expected Q4 [fourth quarter] 2023 and final report expected Q4 [fourth quarter] 2028.
- For all injectable products the Product Information must be included with the product as a package insert.
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.