On June 13, 2026, the U.S. Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that tests positive for PTEN deficiency. The decision marks the first targeted treatment approved specifically for this genetically defined prostate cancer population and underscores the growing role of biomarker-stratified oncology approvals.

The AKT inhibitor capivasertib was evaluated in the Phase III CAPItello-281 trial, a randomised study enrolling 1,012 patients with mAPMN/S prostate cancer. In the PTEN-deficient subgroup, capivasertib plus abiraterone extended radiographic progression-free survival (rPFS) to 33.2 months versus 25.7 months on placebo plus abiraterone, a hazard ratio of 0.81. Primary results were first presented at the 2025 ESMO Congress and subsequently published in the Annals of Oncology.

PTEN, or phosphatase and tensin homolog, is a tumour suppressor gene whose loss activates the PI3K/AKT/mTOR pathway — a well-characterised driver of prostate cancer progression and resistance to androgen deprivation. Loss of PTEN function occurs in approximately 20 to 25 percent of hormone-sensitive metastatic prostate cancers and has historically been associated with poorer outcomes on standard-of-care regimens.

The FDA simultaneously approved the VENTANA PTEN (SP218) RxDx Assay, developed by Ventana Medical Systems and Roche Diagnostics, as a companion diagnostic to identify patients eligible for treatment. Companion diagnostic co-approval has become a standard feature of precision oncology submissions, ensuring that the biomarker test and the therapy are validated in concert.

Capivasertib received its initial FDA approval in November 2023 for AKT1/2/3-mutated or PTEN-deficient HR-positive/HER2-negative breast cancer in combination with fulvestrant. This new prostate cancer indication extends the compound’s commercial reach into a second major tumour type. AstraZeneca’s oncology pipeline has increasingly leaned into molecularly defined indications, and Truqap’s trajectory reflects that strategic posture.

For clinicians, the approval introduces a new treatment decision point: genomic testing for PTEN status at the time of metastatic hormone-sensitive diagnosis is now clinically actionable. This places prostate cancer on a similar trajectory to breast cancer and non-small cell lung cancer, where molecular profiling at diagnosis has become routine practice.
The combination’s tolerability profile includes manageable on-target AKT inhibition effects, primarily hyperglycaemia and rash, which are consistent with earlier data in breast cancer. No new safety signals emerged in CAPItello-281.

With enzalutamide and apalutamide already established in the mAPMN/S setting, capivasertib plus abiraterone positions itself as the preferred option for the PTEN-deficient subset, a strategy that trades broad-market reach for precision in a population with the highest unmet need.