The FDA has approved inavolisib (Itovebi, Genentech) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy (ET). The FDA also approved the FoundationOne Liquid CDx (Foundation Medicine) assay as a companion diagnostic device to identify patients with breast cancer
OCTOBER 11, 2024