On November 17, 2023, Truqap (Capivasertib), a first-in-class AKT inhibitor developed by AstraZeneca, was approved by the U.S. FDA for use in combination with Fulvestrant to treat adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer (carrying at least one PIK3CA, AKT1, or PTEN gene mutation).
The U.S. Food and Drug Administration (FDA) has also approved FoundationOne® CDx, developed by Foundation Medicine, as a companion diagnostic device for detecting whether breast cancer patients are suitable for treatment with capivasertib in combination with fulvestrant.
Regarding Capivasertib
Capivasertib is a highly selective inhibitor of three AKT isoforms (AKT1/2/3). AKT, also known as phosphokinase B (PKB), plays a crucial role in multiple cascade signaling mechanisms involved in cell growth and division, inhibition of apoptosis, and angiogenesis. Activation of the AKT signaling pathway, including alterations in PIK3CA, AKT1, and PTEN, can occur in many HR+/HER2- advanced breast cancer patients, but may also occur in patients without these genetic alterations.
On June 12, 2023, the FDA granted priority review designation to the New Drug Application (NDA) for Capivasertib + fulvestrant, and it was quickly approved in less than six months.
