EMA — authorised 18 July 2025
- Application: EMEA/H/C/006353
- Marketing authorisation holder: Roche Registration GmbH
- Local brand name: Itovebi
- Indication: 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
- Status: approved
The European Medicines Agency (EMA) granted marketing authorisation for Itovebi on 18 July 2025. Itovebi is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer. This indication is for patients who have experienced recurrence on or within 12 months of completing adjuvant endocrine treatment.