FDA Approves TRUQAP as First Targeted Therapy for PTEN-Deficient Prostate Cancer

AstraZeneca’s TRUQAP (capivasertib) has received US approval for treating a specific form of prostate cancer. The drug, used alongside abiraterone and prednisone, targets adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer. This marks the first targeted therapy available for this condition. The approval follows positive results from the CAPItello-281 Phase III trial. Findings were presented at the 2025 ESMO Congress and published in Annals of Oncology. The trial showed a median radiographic progression-free survival of 33.2 months for the TRUQAP combination, compared to 25.7 months for the control group. This represents a 19% reduction in the risk of disease progression or death.

Overall survival data remain incomplete, but early results suggest a numerical advantage for the TRUQAP combination. The treatment addresses a critical need, as about one in four mAPMN/S prostate cancer patients have PTEN-deficient tumours. These tumours are linked to poorer outcomes and can be identified through immunohistochemistry testing at diagnosis.

Prostate cancer is the second most common cancer in men globally, with over 1.4 million diagnoses annually. Around 200,000 patients worldwide, including 35,000 in the US, are diagnosed with mAPMN/S prostate cancer each year. The TRUQAP combination is now the first and only targeted treatment for mAPMN/S prostate cancer. It offers a new option for patients with PTEN-deficient tumours, a group previously facing limited therapies. The approval is expected to improve outcomes for a significant subset of those affected by this disease.