The FDA on June 12, 2026 granted full approval to capivasertib (TRUQAP, AstraZeneca) in combination with abiraterone and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer. On the same day, the agency approved Roche’s VENTANA PTEN (SP218) RxDx Assay, the first immunohistochemistry companion diagnostic to detect PTEN protein loss in prostate adenocarcinoma, enabling clinicians to identify which patients are eligible for the new regimen.

The action is a full approval, not an accelerated pathway decision — a distinction that matters given the prior ODAC vote (7-1 in favor) and the trial’s enrollment scope.

The approval rests on the Phase III CAPItello-281 trial (NCT04493853), which enrolled 1,012 adults with PTEN-deficient tumors confirmed by IHC. Patients were randomized 1:1 to intermittent capivasertib 400 mg twice daily (4 days on / 3 days off) plus abiraterone and androgen deprivation therapy, or placebo plus abiraterone and ADT. The primary endpoint — investigator-assessed radiographic progression-free survival — was met: median rPFS was 33.2 months in the capivasertib arm versus 25.7 months in the placebo arm (HR 0.81; 95% CI 0.66–0.98; P = .034), a 7.5-month absolute improvement. Results were published in the Annals of Oncology (PMID 41120017).

Interim overall survival data, at 26.4% event maturity, showed an HR of 0.90 (95% CI 0.71–1.15; P = .401) — a non-significant and immature result that remains a key secondary endpoint under continued follow-up.

The safety profile reflected on-target AKT pathway toxicity: diarrhea was reported in approximately 52% of patients in the capivasertib arm, hyperglycemia in approximately 38%, and rash in approximately 35%.

The Roche VENTANA PTEN (SP218) RxDx Assay is a qualitative IHC test run on the BenchMark ULTRA automated staining platform. It is the first assay FDA-approved as a companion diagnostic to assess PTEN protein — as opposed to PTEN gene deletion by FISH or sequencing — in prostate cancer tissue. Approximately 25% of patients with mHSPC carry PTEN-deficient tumors; in the CAPItello-281 screened population, 1,519 of 6,003 patients with valid tumor results (25.3%) were PTEN-deficient by IHC.

Capivasertib’s first FDA approval was in November 2023 for HR-positive, HER2-negative advanced breast cancer in combination with fulvestrant, based on CAPItello-291. The prostate cancer approval is the drug’s second indication.

Sources: AstraZeneca press release June 12, 2026; Roche press release June 12, 2026; Annals of Oncology PMID 41120017.