The US Food and Drug Administration (FDA) has approved AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of the most common type of breast cancer.

The pan adenosine triphosphate (ATP)-competitive inhibitor is approved for adult patients with hormone receptor (HR)-positive/ HER2-negative locally advanced or metastatic breast cancer. Patients eligible for the drug will need to have tumours that have one or more of the PIK3CA, AKT1, or PTEN genes altered – present in up to 50% of HR-positive breast cancer cases.

The FDA based its decision on results from the Phase III CAPItello-291 trial (NCT04305496), according to a 17 November press release. The data, which was published in The New England Journal of Medicine, demonstrated that the combination of the two drugs reduced the risk of cancer progression or death by 50% compared to Faslodex alone.

HR-positive is the most common subtype of breast cancer, with HR-positive/HER2- accounting for 69% of female breast cancer cases according to the National Cancer Institute. The approval means patients who have progressed on endocrine therapy or have had recurrence within a year of completing adjuvant therapy now have a new treatment option.

AstraZeneca said that regulatory applications for Truqap are also under review in the European Union, China, and Japan. Following the FDA approval, Astex Therapeutics is now in line for a milestone payment from AstraZeneca upon commencement of commercial sale of the drug, as per a 2005 deal.

Faslodex, also made by AstraZeneca, was approved as a monotherapy for postmenopausal women with HR-positive breast cancer by the FDA in 2002. Its use has since expanded to other settings in breast cancer, including as a combination therapy with Pfizer’s CDK 4/6 inhibitor Ibrance (palbociclib).

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Truqap enters a competitive market, joining the likes of Pfizer’s Ibrance, Eli Lilly’s Verzenio (abemaciclib), and Novartis’ Kisqali (ribociclib)—all approved for HR+ Her2-negative breast cancer.

Following the approval, AstraZeneca’s oncology business executive vice-president Dave Fredrickson said: “This approval provides a critical new option for patients in the US with this specific type of disease and we look forward to bringing Truqap to the many breast cancer patients who can benefit across the globe.”

This content was updated on 25 January 2024