
The Food and Drug Administration (FDA) granted approval to capivasertib (Truqap, AstraZeneca Pharmaceuticals) in combination with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer displaying PIK3CA/AKT1/PTEN-alterations. The approval includes the FoundationOne®CDx assay as a companion diagnostic device. The FDA's decision follows positive outcomes from the CAPItello-291 trial, with a significant improvement in progression-free survival observed in patients with PIK3CA/AKT1/PTEN-altered tumors. The application received priority status and was approved two weeks before the FDA goal date, utilizing expedited programs for serious conditions.
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