Regulatory approval

Published by the European Medicines Agency.

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.

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