Welireg
Registration timeline
The following table summarises the key steps and dates for this application.
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) | 2 February 2022 |
| Submission dossier accepted and first round evaluation commenced | 31 March 2021 |
| First round evaluation completed | 14 September 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 15 November 2021 |
| Second round evaluation completed | 14 January 2022 |
| Delegate’s Overall benefit-risk assessment | 14 October 2022 |
| Sponsor’s pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 20 December 2022 |
| Completion of administrative activities and registration on ARTG | 22 December 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 247 |
*Statutory timeframe for standard applications is 255 working days
Croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, indigo carmine aluminium lake, macrogol, polyvinyl alcohol, purified talc and titanium dioxide.
The recommended dose is 120 mg administered orally, once daily.
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.
Welireg (belzutifan) was approved for the following therapeutic use:
WELIREG (belzutifan) is indicated for the treatment of adult patients with von Hippel‑Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), not requiring immediate surgery.
- Welireg (belzutifan) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Welireg 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 Welireg Core-Risk Management Plan (RMP) (version 3.0, dated 26 October 2021, data lock point 1 June 2020), with Australia specific annex (version 0.6, dated September 2022), included with submission PM-2021-00644-1-4, to be revised to the satisfaction of the TGA, and any subsequent revisions, 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.
- Submit for evaluation carcinogenicity studies conducted in mouse and rat models.
- Submit for evaluation any interim analyses and the final analysis of Study MK-6482-004.
- Submit for evaluation the final study report for study MK-6482-015.