Nubeqa
Registration timeline
The following table summarises the key steps and dates for this application.
This application was evaluated as part of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium, with work-sharing between TGA and Health Canada. Each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 30 May 2019 |
| First round evaluation completed | 19 November 2019 |
| Sponsor provides responses on questions raised in first round evaluation | 6 December 2019 |
| Second round evaluation completed | 29 January 2020 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 3 February 2020 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 20 February 2020 |
| Completion of administrative activities and registration on ARTG | 26 February 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 185 |
*Statutory timeframe for standard applications is 255 working days
Tablet core: Calcium hydrogen phosphate dehydrate, Croscarmellose sodium, Lactose monohydrate, Magnesium stearate, Povidone
Film coat: Hypromellose, Lactose monohydrate, Macrogol 3350, Titanium dioxide
Each film-coated tablet contains 176.9 mg of lactose (as lactose monohydrate).
The recommended dose is 600 mg (two film-coated tablets of 300 mg) darolutamide taken twice daily, equivalent to a total daily dose of 1200 mg.
For further information refer to the Product Information.
Nubeqa (darolutamide) was approved for the following therapeutic use:
Nubeqa is indicated for the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC).
- Submit the final clinical study report for the ARAMIS study when available.
- Nubeqa (darolutamide) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicine Information (CMI) for Nubeqa 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 European Union-Risk Management Plan (EU-RMP) (version 0.1, date 31 January 2019; data lock point (DLP) 3 September 2018), with Australian Specific Annex (version 1.0, dated February 2019), included with submission PM-2019-01420-1-4, 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 this 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 this 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.
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.