Itovebi (inavolisib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Roche Registration GmbH. Itovebi (inavolisib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/itovebi-epar-product-information_en.pdf.pdf. Revised August 2025. Accessed September 8, 2025.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER positive, HER2-negative, PIK3CA somatic variants	Invasive Breast Carcinoma	Fulvestrant, Inavolisib, Palbociclib
Sensitivity (+)	HER2-negative, PIK3CA somatic variants, PR positive	Invasive Breast Carcinoma	Fulvestrant, Inavolisib, Palbociclib
Sensitivity (+)	ER positive, HER2-negative, PIK3CA somatic variants, PR positive	Invasive Breast Carcinoma	Fulvestrant, Inavolisib, Palbociclib