The U.S. Food and Drug Administration (FDA) has approved capivasertib (Truqap) in combination with abiraterone and prednisone for metastatic prostate cancer patients with PTEN deficiency. As the first targeted therapy approved for this patient group, it reinforces the importance of biomarker-based personalization in prostate cancer.
June 12, 2026 — On June 12, 2026, the FDA approved capivasertib (Truqap) in combination with abiraterone and prednisone for the treatment of adult patients with metastatic, androgen pathway modulation –naïve or –sensitive (mAPMN/S) prostate cancer (formerly metastatic hormone-sensitive prostate cancer, mHSPC) whose tumors are PTEN-deficient as determined by an FDA-authorized test.
PTEN deficiency is found in roughly one in four of these patients and is associated with a more aggressive course and poorer prognosis. The VENTANA PTEN (SP218) RxDx Assay, developed to identify eligible patients, received simultaneous FDA approval.
The Basis for Approval: The CAPItello-281 Study
This approval is based on CAPItello-281, a randomized, double-blind, placebo-controlled, multicenter study enrolling 1,012 newly diagnosed patients, who were randomized 1:1 to receive either capivasertib + abiraterone or placebo + abiraterone.
- Significant Delay in Disease Progression: Patients receiving the capivasertib and abiraterone combination had a median radiographic progression-free survival (rPFS) of 33.2 months, compared with 25.7 months in the placebo group.
- Statistical Significance: The combination produced a statistically significant reduction in the risk of disease progression (HR 0.81; 95% CI 0.66–0.98; p=0.034).
💬 Clinical Significance
Capivasertib is an oral inhibitor of all three isoforms of the AKT enzyme (AKT1, AKT2, AKT3). PTEN loss drives overactivation of the PI3K/AKT pathway and is linked to the development of resistance to hormonal therapy; targeting AKT therefore aims to delay disease progression in this resistant subgroup. The approval is notable as the first targeted therapy defined for this patient population.
Dose and Administration
According to the information published by the FDA, the recommended dosing guide is as follows:
| Drug | Recommended Dose | Route and Schedule |
|---|---|---|
| Capivasertib (Truqap) | 400 mg twice daily (about 12 hours apart) | Oral 4 days on, then 3 days off; until disease progression or intolerable toxicity. |
| Abiraterone acetate | 1,000 mg once daily | Oral |
| Prednisone | 5 mg once daily | Oral |
Throughout treatment, patients must concurrently receive a GnRH analog or have previously undergone bilateral orchiectomy (surgical removal of both testicles).
Safety and Side-Effect Profile
Grade 3 and higher (serious) side effects occurred in 67% of patients on the combination therapy; the most frequently reported were rash (12.3%) and hyperglycemia (10.3%).
The prescribing information carries important warnings for the following risks:
- Hyperglycemia (high blood sugar)
- Diarrhea
- Cutaneous (skin) adverse reactions
- Embryo-fetal toxicity
Conclusion
With this approval, capivasertib enters clinical use as the first targeted treatment option defined for PTEN-deficient metastatic prostate cancer. The development once again highlights the growing role of biomarker-based patient selection and personalized approaches in the management of prostate cancer.