Treats endocrine-resistant, PIK3CA -mutated, hormone receptor … metastatic breast cancer. NDA 219249, held by Genentech Inc. Inavolisib.
As of Nov 13, 2026, NDA 219249 (Itovebi), held by Genentech Inc, was first approved by FDA on Oct 10, 2024, with 2 approved supplements and 0 published complete response letters.
ITOVEBI, in combination with palbociclib and fulvestrant, is indicated 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2026 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 10, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Itovebi3MG · tablet;oral | Inavolisib | RxReference drug |
| Itovebi9MG · tablet;oral | Inavolisib | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2026 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Sep 25, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Oct 10, 2024 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
