Capivasertib cleared for PTEN-deficient prostate cancer

On June 12, 2026, the Food and Drug Administration 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 referred to as 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 Medical Systems, Inc./Roche Diagnostics) as a companion diagnostic device to identify patients with PTEN-deficient prostate cancer for treatment with capivasertib.

Full prescribing information for Truqap will be posted here.

Efficacy and Safety

Efficacy was evaluated in CAPItello-281 (NCT04305496), a randomized, double-blind, placebo-controlled, multicenter trial that enrolled 1,012 adults with newly diagnosed, PTEN-deficient mAPMN/S prostate cancer. Tumor PTEN deficiency status was prospectively determined by central testing using the immunohistochemistry-based VENTANA PTEN (SP218) RxDx Assay; PTEN deficiency was defined as ≥ 90% of viable malignant cells with no specific cytoplasmic staining. Patients were randomized 1:1 to receive either capivasertib with abiraterone or placebo with abiraterone. Abiraterone was administered with either prednisone or prednisolone.

The major efficacy outcome measure was investigator-assessed radiographic progression-free survival (rPFS). Overall survival (OS) was an additional efficacy outcome measure. The trial demonstrated a statistically significant improvement in rPFS for capivasertib and abiraterone compared to placebo and abiraterone. Median rPFS was 33.2 months (95% CI: 25.8, 44.2) in the capivasertib arm and 25.7 months (95% CI: 22.0, 29.9) in the placebo arm (hazard ratio 0.81 [95% CI: 0.66, 0.98]; two-sided p-value 0.034). OS results were immature at the time of rPFS analysis.

The prescribing information includes warnings and precautions for hyperglycemia, diarrhea, cutaneous adverse reactions, and embryo-fetal toxicity.

Recommended Dosage

The recommended capivasertib dosage is 400 mg orally twice daily (approximately 12 hours apart) with or without food, for four days followed by three days off until disease progression or unacceptable toxicity. The recommended abiraterone acetate dosage is 1000 mg once daily in combination with prednisone 5 mg once daily. Patients receiving capivasertib and abiraterone acetate should also receive a GnRH analog concurrently or should have had bilateral orchiectomy.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

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