FDA Advisory Committee Recommends Truqap for PTEN-Deficient Prostate Cancer

AstraZeneca's Form 6-K reports that the FDA's Oncologic Drugs Advisory Committee (ODAC) has recommended Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy for the treatment of patients with PTEN-deficient metastatic hormone-sensitive prostate cancer. The Committee voted 7-1 with 1 abstention, recognizing a favorable benefit-risk profile based on results from the CAPItello-281 Phase III trial. This represents the first targeted treatment combination to demonstrate benefit in this specific prostate cancer subtype, addressing a significant unmet medical need. The FDA had previously accepted the supplemental New Drug Application in August 2025. The filing notes that a regulatory application is also under review in the EU, and the FDA will consider but is not bound by the Committee's recommendation.