FDA Approves First Targeted Therapy for PTEN-Deficient Prostate Cancer

AstraZeneca’s TRUQAP (capivasertib) has received US approval for use alongside abiraterone and prednisone. The treatment is now the first and only targeted option for adults with PTEN-deficient mAPMN/S prostate cancer. This form of cancer was previously known as metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is the second most common cancer in men and the fifth leading cause of cancer death globally. Over 1.4 million men receive a diagnosis each year, with around 200,000 cases of mAPMN/S prostate cancer worldwide. In the US alone, approximately 35,000 patients are diagnosed annually with this condition.

About one in four of these patients have PTEN-deficient tumours. These tumours are linked to poorer outcomes and can be identified through immunohistochemistry testing at diagnosis. The approval follows results from the CAPItello-281 Phase III trial, which demonstrated a 19% reduction in the risk of disease progression or death when TRUQAP was added to standard therapy.

The trial also reported a 7.5-month improvement in median radiographic progression-free survival for patients on the TRUQAP combination compared to the control group. The safety profile matched the known effects of each drug. However, 67% of patients on the combination experienced Grade 3 or higher adverse events, with rash and high blood sugar the most common. The new treatment offers a targeted option for patients with PTEN-deficient mAPMN/S prostate cancer. It has shown measurable benefits in delaying disease progression. The approval marks a significant step in addressing a form of cancer with previously limited targeted therapies.