Inavolisib
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Breast cancer1 | |||
PIK3CA mutation, ER-positive, HER2-negative | + palbociclib and fulvestrant | 2L 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 |
Full text of section 4.1 (therapeutic 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.
Label history
2 changes to the Itovebi label since 2026, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes