# Alpelisib

Alpelisib (Piqray, Novartis Europharm Limited) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: PIK3CA (1).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PIK3CA mutation, HR-positive, HER2-negative | + fulvestrant | 2nd line, advanced | Following an endocrine-based regimen; Postmenopausal women, and men |

## Products

### Piqray

- Company: Novartis Europharm Limited
- Target: PI3Kα inhibitor
- Class: Phosphatidylinositol-3-kinase (PI3K) inhibitors
- ATC: L01EM03
- EU approval: 27 Jul 2020
- Label revised: 16 Sep 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/piqray-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/piqray-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/piqray

Mechanism (SmPC section 5.1): Alpelisib selectively inhibits PI3Kα, blocking downstream PI3K/AKT signalling and reducing tumour growth in cancers harbouring PIK3CA mutations.

## Label wording

- **Alpelisib** (Piqray), Breast cancer, 2nd line, advanced: “Piqray is indicated 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 an endocrine-based regimen (see section 5.1 and for biomarker-based patient selection see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/piqray-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/alpelisib