NewsoncologyJun 5, 2026
FDA Approves Companion Diagnostic for Inavolisib in HR+/HER2–, PIK3CA-Mutated Breast Cancer
The FDA has approved FoundationOne CDx as a companion diagnostic for inavolisib (Itovebi) in combination with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. This approval expands the targeted therapy landscape and underscores the importance of genomic testing in patient selection.
Dr. Sarah Mitchell
