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Truqap (capivasertib)
Australian Prescription Medicine Decision Summary
Sponsor
ARTGs
Device/Product name
Truqap
Active Ingredient
Capivasertib
Date of decision
Published
Submission type
Category A (New Chemical Entity)
ATC codes
L01EX27 (protein kinase inhibitors)
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy studies conducted in humans) and risk management plan information submitted by the sponsor.
What steps were involved in the decision process
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
Date of entry onto ARTG
Black triangle scheme
Truqap (capivasertib) is to be included in the Black Triangle Scheme. The black triangle is a visual reminder to encourage health practitioners and patients to report problems or side effects experienced with this medicine. The PI and CMI for Truqap must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date of first supply of the product.
Dose forms
Film-coated tablet
Strength
160mg, 200mg.
Other ingredients
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.
Containers
Aluminium blisters
Pack sizes
64 tablets
Routes of administration
Oral
Dosage
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.
Pregnancy category
D:
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.
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.
What was approved
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.
What is this medicine and how does it work
Truqap (capivasertib) is an anti-cancer drug that blocks the activity of a protein called AKT, which is important for cell growth and survival. AKT is often overactive in cancer cells, helping them to grow and survive. Capivasertib can stop the growth of cancer cells by blocking AKT. It has been shown to be effective in reducing the growth of cancer cells in the laboratory and in animal models. In this submission, capivasertib was approved for use in combination with another anti-cancer drug, fulvestrant. Combined treatment with capivasertib and fulvestrant demonstrated a greater anti-tumour response than with fulvestrant alone.
What post-market commitments will the sponsor undertake
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.