Advice

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.

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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