Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized 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. 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 as:

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.

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.

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.