Truqap (capivasertib)
This submission was evaluated under the standard prescription medicines registration process
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 31 May 2023 |
| First round evaluation completed | 16 November 2023 |
| Sponsor provides responses on questions raised in first round evaluation | 12 December 2023 |
| Second round evaluation completed | 31 January 2024 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice [if applicable] | 29 February 2024 |
| Sponsor’s pre-Advisory Committee response | 14 March 2024 |
| Advisory Committee meeting | 22 April 2024 |
| Registration decision (Outcome) | 7 May 2024 |
| Completion of administrative activities and registration on ARTG | 9 May 2024 |
| Number of working days from submission dossier acceptance to registration decision* | 207 |
*Statutory timeframe for standard submissions is 255 working days
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide, macrogol 3350, polydextrose, copovidone, medium chain triglycerides, iron oxide black, iron oxide red, iron oxide yellow.
The recommended dose of Truqap in combination with fulvestrant is 400 mg (two 200 mg tablets) taken orally twice daily approximately 12 hours apart (total daily dose of 800 mg) with or without food, for 4 days followed by 3 days off treatment.
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.
Truqap, in combination with fulvestrant, was approved for the for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen.
Clinical Data Commitments:
- Submit all (as yet unsubmitted) interim and final clinical study reports of the CAPITello-291 trial to the TGA as soon as they become available (CAPItello-291 is the pivotal phase III randomised controlled trial supporting this submission).
- Submit all clinical study reports of the hepatic impairment clinical trial evaluating the PK and safety of capivasertib in patients with moderate hepatic impairment (FDA PMR 4548-3) to the TGA as soon as they become available.
- Submit all clinical study reports of the clinical drug interaction study evaluating the effect of repeat doses of capivasertib on the pharmacokinetics and safety of transporter substrates of BCRP, OATP1B1 and OATP1B3 (FDA PMR 4548-4) to the TGA as soon as they become available.
RMP Commitments:
- The Truqap Risk Management Plan (RMP) as agreed with the TGA will be implemented in Australia. An obligatory component of RMPs is routine pharmacovigilance, which includes the submission of periodic safety update reports.
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.