FDA Approves Capivasertib Combo for PTEN-Deficient Prostate Cancer

The U.S. Food and Drug Administration has approved AZN AstraZeneca's Truqap (capivasertib), in combination with abiraterone and androgen deprivation therapy, as the first and only targeted treatment for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer. Capivasertib is a first-in-class inhibitor of all three AKT isoforms; PTEN loss drives dysregulation of the PI3K/AKT pathway and is associated with poorer outcomes, which is why an AKT-targeted approach is biologically rational in this subgroup.

The approval pairs the therapy with a companion diagnostic. Roche's VENTANA PTEN (SP218) RxDx Assay is cleared to identify PTEN-deficient tumors, defining the biomarker-selected population eligible for treatment. The clearance follows Phase III evidence (CAPItello-281) showing a statistically significant improvement in radiographic progression-free survival versus the standard-of-care backbone.

For AZN, the decision extends Truqap beyond its existing breast-cancer franchise into prostate cancer, one of the most common solid tumors, and reinforces AstraZeneca's biomarker-led oncology strategy. The commercial questions to watch are PTEN-deficient testing rates in routine urology and oncology practice, payer coverage, and how quickly the combination is adopted against established treatment regimens.