Posted by Michael Wonder on 10 Oct 2024
FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer
10 October 2024 - Today, the FDA approved inavolisib (Itovebi, Genentech) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor positive, human epidermal growth-factor receptor 2 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.
