Itovebi (inavolisib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Genentech, Inc. Itovebi (inavolisib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219249s000lbl.pdf. Revised October 2024. Accessed October 30, 2024.

Regulatory approvals

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

Indication

Statements

ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

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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