Itovebi (inavolisib)
- Region
- 🇪🇺 EU
- Active substance
- inavolisib
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Thu 22 May 2025
- EU approval
- Fri 18 Jul 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006353
- Official record
- www.ema.europa.eu
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 therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.