FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer
Regulatory approval: On June 12, 2026, the FDA approved capivasertib (Truqap) plus abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer that is PTEN-deficient, as detected by an FDA-authorized test. Approval was supported by CAPItello-281, which showed a statistically significant investigator-assessed rPFS improvement versus placebo plus abiraterone (median 33.2 vs 25.7 months; HR 0.81). OS data were immature at the rPFS analysis.
FDA approval (June 12, 2026)
The US Food and Drug Administration (FDA) approved capivasertib (Truqap; AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously termed metastatic hormone-sensitive prostate cancer) that is PTEN-deficient, as detected by an FDA-authorized test.
The FDA also approved the VENTANA PTEN (SP218) RxDx Assay (Ventana/Roche) as a companion diagnostic to identify patients with PTEN-deficient prostate cancer for treatment with capivasertib.
Supporting trial evidence
Efficacy and safety were evaluated in CAPItello-281 (NCT04305496), a randomized, double-blind, placebo-controlled, multicenter trial enrolling 1,012 adults with newly diagnosed, PTEN-deficient mAPMN/S prostate cancer. PTEN deficiency was prospectively determined by central IHC using the companion assay and defined as ≥90% of viable malignant cells with no specific cytoplasmic staining.
Patients were randomized 1:1 to capivasertib + abiraterone or placebo + abiraterone; abiraterone was given with prednisone or prednisolone. The primary endpoint was investigator-assessed radiographic PFS (rPFS).
- Median rPFS: 33.2 months vs 25.7 months (HR 0.81, 95% CI 0.66–0.98; p=0.034)
- Overall survival: results were immature at the time of rPFS analysis
Key safety information in labeling
Warnings/precautions include hyperglycemia, diarrhea, cutaneous adverse reactions, and embryo-fetal toxicity.
Dosing (per FDA)
Capivasertib 400 mg orally twice daily (4 days on/3 days off). Abiraterone acetate 1000 mg once daily with prednisone 5 mg once daily; patients should also receive a GnRH analog or have had bilateral orchiectomy.