FDA Approves Itovebi for the Combination Treatment of Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation
Genentech announced that the U.S. Food and Drug Administration (FDA) approved Itovebi (inavolisib), in combination with palbociclib (Ibrance) 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.
- The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers. HRpositive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases.
- The Itovebi-based regimen was granted FDA Priority Review and Breakthrough Therapy Designation in May 2024 based on the INAVO120 study results.
- Itovebi will be available in the U.S. in the coming weeks.
Source: Genentech, Inc.
