U.S. Food and Drug Administration (FDA)
FDA Approves Inavolisib With Palbociclib and Fulvestrant for Endocrine-Resistant, PIK3CA-Variant, HR-Positive, HER2-Negative, Advanced Breast Cancer
On October 10, 2024, the U.S. Food and Drug Administration (FDA) approved inavolisib (Itovebi™) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-variant, 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.
October 11, 2024