FDA Approves Truqap (Capivasertib) Combo for PTEN-Deficient Prostate Cancer

The FDA approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naive or -sensitive prostate cancer that is PTEN-deficient, as detected by the newly co-approved VENTANA PTEN (SP218) RxDx companion diagnostic assay. It is the first targeted treatment for this PTEN-deficient patient population. The approval was based on the Phase 3 CAPItello-281 trial, which showed a 19% reduction in the risk of radiographic disease progression or death and a median radiographic progression-free survival of 33.2 months for the capivasertib arm versus 25.7 months for abiraterone plus androgen-deprivation therapy and placebo.