AstraZeneca’s Truqap (capivasertib) moved a step closer to a potential label expansion in prostate cancer, following a favorable recommendation from the FDA’s Oncologic Drugs Advisory Committee (ODAC) for its use in combination with abiraterone and androgen deprivation therapy (ADT) in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC).

What was ODAC’s decision?

The committee voted 7 to 1, with one abstention, concluding that the available data supported a favorable benefit-risk profile for the combination based on results from the Phase III CAPItello-281 trial.¹ While the FDA is not bound by advisory committee recommendations, such votes often carry significant weight in regulatory decision-making.

The supplemental New Drug Application for the regimen was accepted by the FDA in August 2025 and was supported by data presented at the European Society for Medical Oncology Congress and published in Annals of Oncology. The application targets a subset of prostate cancer patients characterized by PTEN deficiency, a biomarker associated with more aggressive disease and poorer outcomes.

Truqap is already approved in combination with Faslodex for advanced HR-positive breast cancer, receiving approval back in 2023.

“Patients identified to have PTEN-deficient metastatic hormone-sensitive prostate cancer have an aggressive form of the disease and currently experience poor outcomes,” said Daniel George, MD, director of Genitourinary Oncology at Duke Cancer Institute and a trial investigator. “In addition to this poor prognosis, patients currently have limited treatment options, which is why today’s recommendation of the capivasertib combination is welcome news for both patients and clinicians to address an urgent need for new treatments that delay progression.”

How did Truqap preform in the trials?

The CAPItello-281 trial demonstrated a statistically significant 19% reduction in the risk of radiographic disease progression or death for patients receiving the Truqap combination compared to abiraterone and ADT alone.² Median radiographic progression-free survival improved by 7.5 months, reaching 33.2 months versus 25.7 months in the control arm.

Secondary endpoints also supported the regimen’s clinical benefit. Patients treated with the Truqap combination experienced prolonged time to castration resistance (29.5 months versus 22.0 months) and improvements in prostate-specific antigen progression and symptomatic skeletal event-free survival, indicating a broader impact on disease control.²

Susan Galbraith, Executive vice president, Oncology Haematology R&D at AstraZeneca, emphasized the significance of targeting this patient population. “CAPItello-281 is the first pivotal trial to prospectively define PTEN-deficient metastatic hormone-sensitive prostate cancer and its severe course of disease,” she said. “The Committee’s recognition of the unmet need in patients with PTEN-deficiency and of the benefit seen with the Truqap combination verifies its potential to address this significant need and optimize outcomes for patients.”

Overall survival data remains immature, although interim analyses have shown a numerical trend favoring the Truqap regimen. The study is ongoing to further evaluate survival outcomes as a key secondary endpoint².

The safety profile of the combination was generally consistent with the known effects of its components, though the addition of capivasertib was associated with a higher incidence of Grade 3 or higher adverse events (67% versus 40.4% in the control arm). The most common severe adverse events included rash, hyperglycemia, hypokalemia, diarrhea, hypertension, and anemia.²

The ODAC review highlights increasing regulatory focus on biomarker-defined populations, where targeted therapies may offer more meaningful clinical benefit despite narrower indications.

If approved, the Truqap combination could become a new treatment option for approximately one in four patients with mHSPC who exhibit PTEN deficiency.¹

A separate regulatory application for the regimen is also under review in the European Union, reflecting broader global interest in expanding targeted treatment strategies in prostate cancer.

Sources

1. Truqap (capivasertib) recommended by FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer AstraZeneca April 30, 2026 https://www.businesswire.com/news/home/20260430931552/en/TRUQAP-capivasertib-recommended-by-FDA-Advisory-Committee-for-PTEN-deficient-metastatic-hormone-sensitive-prostate-cancer
2. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study National Library of Medicine October 19, 2025 https://pubmed.ncbi.nlm.nih.gov/41120017/