17Nov 2023
FDA Approves Capivasertib in Combination with Fulvestrant for Advanced Breast Cancer with Specific Genetic Alterations

FDA Approves Capivasertib in Combination with Fulvestrant for Advanced Breast Cancer with Specific Genetic Alterations

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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