WILMINGTON, Del. — AstraZeneca said the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee voted in favor of the benefit-risk profile for TRUQAP in combination with abiraterone and androgen deprivation therapy for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer.
The committee voted 7 to 1, with one abstention, after reviewing data from the Phase III CAPItello-281 trial. The FDA is not required to follow the committee’s recommendation, but the vote will be considered as the agency reviews AstraZeneca’s supplemental New Drug Application for the treatment combination.
The FDA accepted the application in August 2025, based on positive CAPItello-281 results presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.
“Patients identified to have PTEN-deficient metastatic hormone-sensitive prostate cancer have an aggressive form of the disease and currently experience poor outcomes. Their disease significantly impacts their quality of life and inevitably progresses to more advanced stages that are associated with high mortality rates. 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,” said Daniel George, MD, Director of Genitourinary Oncology at Duke Cancer Institute and investigator for the trial.
TRUQAP, also known as capivasertib, is being evaluated as part of a targeted treatment approach for a prostate cancer subtype associated with PTEN deficiency. AstraZeneca said the combination would address a significant unmet need for patients with this form of metastatic hormone-sensitive prostate cancer.
“CAPItello-281 is the first pivotal trial to prospectively define PTEN-deficient metastatic hormone-sensitive prostate cancer and its severe course of disease. 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. We are committed to working closely with the FDA to bring the first and only targeted treatment option to the one in four patients with this form of metastatic hormone-sensitive prostate cancer,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca.
In the primary analysis, the TRUQAP combination reduced the risk of radiographic disease progression or death by 19% compared with abiraterone and androgen deprivation therapy plus placebo. Median radiographic progression-free survival was 33.2 months in the TRUQAP arm, compared with 25.7 months in the comparator arm.
The trial also showed consistent benefit across key secondary endpoints, including time to castration resistance, prostate-specific antigen progression and symptomatic skeletal event-free survival. Overall survival data were immature at the time of the primary analysis, although subsequent interim results numerically favored the TRUQAP combination, according to AstraZeneca.
The company said the safety profile of TRUQAP in combination with abiraterone and androgen deprivation therapy was broadly consistent with the known profile of each medicine. Grade 3 or higher adverse events occurred in 67% of patients receiving the TRUQAP combination, compared with 40.4% of patients in the placebo arm. The most common Grade 3 or higher adverse events in the TRUQAP group included rash, hyperglycemia, hypokalemia, diarrhea, hypertension and anemia.
AstraZeneca said a regulatory application for TRUQAP in combination with abiraterone and androgen deprivation therapy for PTEN-deficient metastatic hormone-sensitive prostate cancer is also under review in the European Union.
