The FDA has approved capivasertib (Truqap) in combination with abiraterone and prednisone for adults with PTEN-deficient metastatic hormone-sensitive prostate cancer. The agency also approved a companion diagnostic test to identify PTEN deficiency, a genetic alteration linked to more aggressive disease and found in about 25% of prostate cancer cases.
The approval is based on results from the phase 3 CAPItello-281 trial, which enrolled more than 1,000 patients. All patients received standard hormone therapy and abiraterone, along with either capivasertib or placebo.
The addition of capivasertib significantly improved radiographic progression-free survival. Across all patients, median progression-free survival increased from 25.7 months to 33.2 months. In patients with complete PTEN loss, the benefit was even greater, with progression-free survival improving from 22.1 months to 34.1 months.
Overall survival data are not yet mature, but early results favor the capivasertib group.
The most common serious side effects were rash and high blood sugar. Despite these risks, the approval marks the first biomarker-guided targeted therapy for this group of patients and represents a major advance in personalized prostate cancer treatment.