AstraZeneca says FDA AdCom recommend Truqap in mHSPC

The company states: “The US Food and Drug Administration’s Oncologic Drugs Advisory Committee has recognised a favorable benefit risk profile for AstraZeneca’s (AZN) Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for the treatment of patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), based on the CAPItello-281 Phase III trial. The Committee voted 7 to 1, with 1 abstaining. In August 2025, the FDA accepted the supplemental New Drug Application (sNDA) for Truqap in combination with abiraterone and ADT based on positive results from the CAPItello-281 Phase III trial, presented at the 2025 European Society for Medical Oncology (ESMO) Congress and simultaneously published in Annals of Oncology. Results from the primary analysis of the CAPItello-281 Phase III trial showed a statistically significant 19% reduction in the risk of radiographic disease progression or death and a clinically meaningful improvement in median radiographic progression-free survival (rPFS) of 7.5 months with the Truqap combination versus treatment with abiraterone and ADT with placebo (based on a hazard ratio (HR) of 0.81; 95% confidence interval (CI) 0.66-0.98; p=0.034). Median rPFS was 33.2 months for the Truqap combination versus 25.7 months for the comparator arm.”