Regulatory approval
Published by the European Medicines Agency. Approved
Itovebi, in combination with palbocicliab 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. 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.
This is written in the approval document.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| EMA (1) | ER positive, HER2-negative, PIK3CA oncogenic variants | Invasive Breast Carcinoma | Fulvestrant, Inavolisib, Palbociclib | |
| EMA (1) | HER2-negative, PIK3CA oncogenic variants, PR positive | Invasive Breast Carcinoma | Fulvestrant, Inavolisib, Palbociclib | |
| EMA (1) | ER positive, HER2-negative, PIK3CA oncogenic variants, PR positive | Invasive Breast Carcinoma | Fulvestrant, Inavolisib, Palbociclib |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2025-09-08 | Van Allen lab | On 2025-08-27, the EMA approved Itovebi (inavolisib) in combination with palbocicliab and fulvestrant for the treatment of adult patients with PIK3CA-mutated, estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. |
| 2025-07-18 | European Medicines Agency | Indication received approval from the European Commission. |