RESUME

On October 10, 2024, the Food and Drug Administration approved inavolisib (Itovebi, Genentech, Inc.) with palbociclib and fulvestrant for 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.

FDA also approved the FoundationOne Liquid CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with inavolisib with palbociclib and fulvestrant.

Full prescribing information for Itovebi will be posted onDrugs@FDA (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm)