Indications
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). Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence.
In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist.
Composition
- Active substance
- inavolisib
Official product information
The European public assessment report holds the summary of product characteristics and the package leaflet in every EU language.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Medicine
- Itovebi
- Active substance
- inavolisib
- Therapeutic area
- Breast Neoplasms
- Marketing authorisation holder
- Roche Registration GmbH
- Status
- Authorised
- EU authorisation
- 18 Jul 2025
- EMA product number
- EMEA/H/C/006353
EMA designations
- Orphan medicine
- No
- Conditional approval
- No
- Biosimilar
- No
- Generic
- No
- Accelerated assessment
- No
- Additional monitoring
- Yes
- Patient safety information
- No