AstraZeneca’s Truqap Approved in US in Combination for Prostate Cancer Treatment

Editor’s Take: This first and only targeted treatment approved in the United States addresses a high priority in prostate cancer management.

AstraZeneca’s Truqap (capivasertib) gained U.S. FDA approval, combined with abiraterone and prednisone, for treatment of certain adults with prostate cancer.

The type of prostate cancer specified is PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S). This was previously metastatic hormone-sensitive prostate cancer (mHSPC).

Truqap is the first and only targeted treatment for adult patients in the United States with PTEN-deficient mAPMN/S prostate cancer. A regulatory application for the Truqap combination approved by the FDA is under review in the European Union.

Prostate Cancer Diagnosis Specs

More than 1.4 million people receive a prostate cancer diagnosis each year. In men, it is the second-most prevalent cancer, and the fifth-leading cause of male cancer death globally. Approximately 200,000 patients annually—35,000 in the U.S.—find out they have mAPMN/S prostate cancer.

Then, of those, about 1 in 4 patients have PTEN-deficient tumors. These fuel cancer cell growth and are a defining characteristic in aggressive disease resulting in poor outcomes.

While PTEN deficiency is a risk factor independent of other characteristics, it can be identified by immunohistochemistry testing at diagnosis.

The approval the FDA granted to Truqap was based on positive results from a Phase III trial (CAPItello-281). These published results can be found in the January 2026 edition of Annals of Oncology.

Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZenece, applauded the FDA’s approval.

“CAPItello-281 showed that for the first time, we can target a key driver of this disease,” Fredrickson said. “[This] makes clear the importance of testing for actionable biomarkers, including PTEN deficiency, in prostate cancer.”

AstraZeneca History with Truqap

Concurrent with its approval, the FDA also cleared a companion diagnostic test. This detects PTEN deficiency in tumors of patients with prostate adenocarcinoma.

AstraZeneca discovered Truqap in collaboration with Astex Therapeutics, which received a 2023 milestone payment for approval in metastatic breast cancer.