Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration (FDA) granted approval to inavolisib in combination with palbociclib and fulvestrant for the treatment of adult patients 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 as:
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.
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.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 |