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AZ first to AKT finish line, but FDA clears narrow label

November 17, 2023

Capivasertib has been approved as Truqap for use in combination with AZ’s oestrogen receptor antagonist Faslodex (fulvestrant) for adults with hormone receptor (HR)-positive and HER2-negative locally advanced or metastatic breast cancer, but only if they also have PIK3CA, AKT1, or PTEN mutations.

It can be used in patients whose disease has progressed despite prior endocrine therapy or has recurred within 12 months of adjuvant (post-surgery) treatment.

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