FDA Approves Capivasertib Plus Abiraterone for PTEN-Deficient Metastatic Hormone-Sensitive Prostate Cancer
Clinical Summary:
- Design/Population: The phase 3 CAPItello-281 trial evaluated capivasertib plus abiraterone and prednisone vs placebo plus abiraterone and prednisone in patients with newly diagnosed PTEN-deficient metastatic androgen pathway modulation–naïve or –sensitive prostate cancer.
- Key Outcomes: Capivasertib plus abiraterone significantly improved radiographic progression-free survival compared with abiraterone alone.
Clinical Relevance: Based on these results, the FDA has approved this regimen. This approval introduces a biomarker-driven treatment option for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer.
On June 12, 2026, the US Food and Drug Administration (FDA) approved capivasertib (Truqap, AstraZeneca) plus abiraterone and prednisone for adult patients with metastatic androgen pathway modulation–naïve or –sensitive prostate cancer that is PTEN-deficient, as determined by an FDA-authorized test. This approval was based on results from the phase 3 CAPItello-281 trial.
In this double-blind, placebo-controlled study, 1012 patients with newly diagnosed patients were randomized 1:1 to receive either capivasertib plus abiraterone or placebo plus abiraterone. Abiraterone was administered with either prednisone or prednisolone. PTEN deficiency was prospectively determined using the immunohistochemistry-based VENTANA PTEN (SP218) RxDx Assay. The primary end point was investigator-assessed radiographic progression-free survival (rPFS). A key secondary end point was overall survival (OS).
At analysis, median rPFS was 33.2 months in the capivasertib arm and 25.7 months in the placebo arm (hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.66 to 0.98; P = .034). OS data were immature at the time of the rPFS analysis.
The recommended dose of capivasertib is 400 mg twice daily for 4 days on and 3 days off each week in combination with abiraterone and prednisone or prednisolone until disease progression or unacceptable toxicity.
The prescribing information includes warnings and precautions for hyperglycemia, diarrhea, cutaneous adverse reactions, and embryo-fetal toxicity.
The FDA also approved the VENTANA PTEN (SP218) RxDx Assay (Ventana Medical Systems/Roche Diagnostics) as a companion diagnostic to identify eligible patients with PTEN-deficient disease.
Source:
US Food and Drug Administration. FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer. Accessed June 12, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation
