FDA Advisory Committee recommends TRUQAP for prostate cancer subtype

The FDA's Oncologic Drugs Advisory Committee voted 7 to 1 to recommend AstraZeneca's (NYSE: AZN) TRUQAP (capivasertib) in combination with abiraterone and androgen deprivation therapy for treating patients with PTEN-deficient metastatic hormone-sensitive prostate cancer.

The recommendation is based on results from the CAPItello-281 Phase III trial, which showed a 19% reduction in the risk of disease progression or death with the TRUQAP combination compared to abiraterone and androgen deprivation therapy with placebo. Median radiographic progression-free survival was 33.2 months for the TRUQAP combination versus 25.7 months for the comparator arm.

The FDA accepted AstraZeneca's supplemental New Drug Application for TRUQAP in this indication in August 2025. The application is under review, with the FDA not bound by the advisory committee's recommendation.

PTEN-deficient metastatic hormone-sensitive prostate cancer affects approximately one in four patients with this form of the disease. The condition is associated with poor outcomes and limited treatment options.

In the trial, grade 3 or higher adverse events occurred in 67% of patients treated with the TRUQAP combination versus 40.4% of patients treated with the comparator arm. The most common severe adverse events in the TRUQAP group were rash, hyperglycemia, and hypokalemia.

A regulatory application for TRUQAP in this indication is also under review in the European Union.

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