FDA Approval in PTEN-Deficient Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
June 23, 2026
FDA Approval of Capivasertib with Abiraterone and Prednisone in PTEN-Deficient Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
Hope Rugo, MD, FASCO, Elisabeth Heath, MD, FACP, Daniel George, MD, and Neeraj Agarwal, MD, FASCO
Neeraj Agarwal hosts a discusion with Elisabeth Heath, Hope Rugo, and Daniel George on the CAPItello-281 trial. The trial screened over 6,000 patients to enroll 1,000 with 90% or greater PTEN loss on IHC, randomized to ADT plus abiraterone and prednisone with or without capivasertib, an AKT inhibitor dosed twice daily for four days on and three days off.
FDA Approves Truqap Combination for PTEN-Deficient Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
PRESS RELEASE
The FDA has approved TRUQAP® (capivasertib) plus abiraterone and prednisone as the first targeted treatment for PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer. The approval was based on CAPItello-281, which showed a 19% reduction in the risk of radiographic progression or death and a median rPFS improvement from 25.7 to 33.2 months.
