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TRUQAP® (capivasertib) combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer
WILMINGTON, Del., June 12, 2026--AstraZeneca’s TRUQAP® (capivasertib) in combination with abiraterone and prednisone has been approved in the US as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC), as detected by a US Food and Drug Administration (FDA)-authorized test.1
About this update from Astrazeneca Plc
Based on results of CAPItello-281 which prospectively defined PTEN-deficient disease and showed TRUQAP combination reduced risk of radiographic disease progression or death by 19% First-in-class AKT inhibitor moves into second tumor type to address an aggressive form of prostate cancer associated with poor prognosis WILMINGTON, Del., June 12, 2026--(BUSINESS WIRE)--AstraZeneca’s TRUQAP® (capivasertib) in combination with abiraterone and prednisone has been approved in the US as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC), as detected by a US Food and Drug Administration (FDA)-authorized test.1 The approval by the US FDA was based on positive results from the CAPItello-281 Phase III trial, presented at the 2025 European Society for Medical Oncology (ESMO) Congress and published in Annals of Oncology.2 Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally, with more than 1.4 million people diagnosed each year.3 Of these, approximately 200,000 patients worldwide, including 35,000 in the US, are diagnosed with mAPMN/S prostate cancer annually.4 One in four of these patients have PTEN-deficient tumors, which fuels the growth of cancer cells and defines an aggressive form of the disease associated with poor outcomes.4-7 PTEN deficiency is an independent risk factor regardless of other clinical characteristics, and can be identified by immunohistochemistry testing at time of diagnosis.7 Daniel George, MD, Director of Genitourinary Oncology at Duke Cancer Institute and investigator for the CAPItello-281 trial, said: "Patients with PTEN-deficient metastatic hormone-sensitive prostate cancer, now called metastatic androgen pathway modulation-naïve or sensitive prostate cancer, experience faster progression and worse prognosis than those without PTEN deficiency. Keeping patients with this form of prostate cancer in remission and free from disease progression as long as possible is a high priority. Today’s landmark approval of the capivasertib combination as the first and only targeted treatment option for these patients represents a significant clinical advance with the potential to improve their lives and...