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Device/Product name
Active Ingredient
Date of decision
Submission type
New chemical entity
ATC codes
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 Nubeqa 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.

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

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
Film coated tablet
300 mg
Other ingredients

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).

Blister pack, bottle
Pack sizes
Blister pack: 112 tablets (7 x 16)Bottle: 120 tablets
Routes of administration

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.

Pregnancy category
DDrugs 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.
What was approved

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).
What is this medicine and how does it work
Darolutamide is a non-steroidal androgen receptor antagonist with a flexible polar-substituted pyrazole structure that binds with nanomolar affinity directly to the receptor ligand binding domain to retain antagonistic activity against the androgen receptor (AR).Darolutamide competitively inhibits androgen binding, androgen receptor nuclear translocation and AR mediated transcription.Darolutamide had significant in vivo anti-tumour efficacy (decreased tumour cell proliferation) leading to decreased tumour volume in xenograft models of prostate cancer implemented in mice, including the castration-resistant model VCaP which overexpresses the AR.
What post-market commitments will the sponsor undertake
  • 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 Medicines 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.

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