FDA approves FoundationOne CDx as Itovebi companion diagnostic in PIK3CA-mutated breast cancer

  • FDA cleared FoundationOne CDx as a companion diagnostic for Genentech’s Itovebi (inavolisib) regimen in PIK3CA-mutated HR-positive, HER2-negative breast cancer.
  • The tissue test expands access beyond FoundationOne Liquid CDx, which received the same companion diagnostic indication in October 2024.


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