following a full submission assessed under the end of life and orphan equivalent medicine process:
capivasertib (Truqap®) is not recommended for use within NHSScotland.
Indication under review: in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (defined as IHC 0 or 1+, or IHC 2+/ISH-) locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.
In a double-blind, phase III study, addition of capivasertib to fulvestrant significantly improved progression-free survival in adults with locally advanced or metastatic HR-positive HER2-negative breast cancer with one or more PIK3CA/AKT1/PTEN-alterations who had recurrence or progression on or after an aromatase inhibitor-based regimen.
The company did not present a sufficiently robust economic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Medicine details
- Medicine name:
- capivasertib (Truqap)
- SMC ID:
- SMC2823
- Indication:
In combination with fulvestrant for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (defined as IHC 0 or 1+, or IHC 2+/ISH-) locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine based regimen.
- Pharmaceutical company
- AstraZeneca UK Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Not recommended
- Date advice published
- 13 October 2025