FDA Approves New Test to Expand Access to Targeted Breast Cancer Therapy
The U.S. FDA has approved FoundationOne CDx, a tissue-based companion diagnostic test, to identify patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative advanced or metastatic breast cancer who may benefit from treatment with inavolisib (Itovebi) combined with palbociclib (Ibrance) and fulvestrant (Faslodex). The approval provides an important alternative to the previously authorized blood-based FoundationOne Liquid CDx, helping […]
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