Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) ER positive, HER2-negative, PIK3CA Somatic variants Invasive Breast Carcinoma Fulvestrant, Inavolisib, Palbociclib
FDA (1) HER2-negative, PIK3CA Somatic variants, PR positive Invasive Breast Carcinoma Fulvestrant, Inavolisib, Palbociclib
FDA (1) ER positive, HER2-negative, PIK3CA Somatic variants, PR positive Invasive Breast Carcinoma Fulvestrant, Inavolisib, Palbociclib