Posted by Michael Wonder on 05 Jun 2026
US FDA approves FoundationOne CDx as a companion diagnostic for Itovebi (inavolisib) to identify patients with hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
2 June 2026 - Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne CDx to be used as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant.
This decision from the FDA follows the approval of FoundationOne Liquid CDx, Foundation Medicine’s blood-based comprehensive genomic profiling test, for the same therapy combination and indication in October 2024.
