# Inavolisib

Inavolisib (Itovebi, Roche Registration GmbH ) 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, ER-positive, HER2-negative | + palbociclib and fulvestrant | 2nd line, advanced | After adjuvant endocrine treatment with recurrence on or within 12 months of completion (if previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting, an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and detection of recurrence is required); In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist |

## Products

### Itovebi

- Company: Roche Registration GmbH 
- Target: PI3Kα inhibitor and mutant degrader
- EU approval: 18 Jul 2025
- Label revised: 8 May 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/itovebi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/itovebi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/itovebi

Mechanism (SmPC section 5.1): Inavolisib inhibits the PI3K catalytic subunit alpha (p110α) and degrades mutated p110α, reducing downstream PI3K/AKT signalling, cell proliferation and survival.

## Label wording

- **Inavolisib** (Itovebi), Breast cancer, 2nd line, advanced: “Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/itovebi-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/inavolisib