in the absence of a submission from the holder of the marketing authorisation:
alpelisib (Piqray®) is not recommended for use within NHSScotland.
Indication under review: in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
Download detailed advice619KB (PDF)
Medicine details
- Medicine name:
- alpelisib (Piqray)
- SMC ID:
- SMC2339
- Indication:
In combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.
- Pharmaceutical company
- Novartis Pharmaceuticals UK Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Non submission
- Status
- Not recommended
- Date advice published
- 08 February 2021