FDA advisory committee backs AstraZeneca’s Truqap for aggressive prostate cancer

The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of AstraZeneca’s (NYSE:AZN) Truqap (capivasertib) for patients with a particularly aggressive form of prostate cancer.

In a 7-1 vote, with one abstention, the committee recognized a favorable benefit-risk profile for the drug when used in combination with abiraterone and androgen deprivation therapy (ADT) for PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC).

The recommendation is based on the CAPItello-281 Phase III trial, which prospectively identified the PTEN-deficient subpopulation—a group that accounts for approximately one in four mHSPC cases and typically faces a poorer prognosis.

Results showed the Truqap combination reduced the risk of radiographic disease progression or death by 19% compared to the standard-of-care combination of abiraterone, ADT, and a placebo.

Patients receiving the Truqap regimen saw a median radiographic progression-free survival (rPFS) of 33.2 months, a 7.5-month improvement over the 25.7 months observed in the comparator arm.

Clinicians highlighted the urgent need for targeted options in this space, noting that PTEN-deficient disease often progresses rapidly to high-mortality stages.

Beyond the primary endpoint, the trial demonstrated improvements in time to castration resistance and prostate-specific antigen (PSA) progression.

While overall survival data remain immature, interim results have numerically favored the Truqap arm, and the trial will continue to monitor this metric.

The safety profile was characterized as manageable and consistent with previous studies, though the addition of Truqap increased the incidence of Grade 3 or higher adverse events to 67%, compared to 40.4% in the control group.

The most frequent severe side effects included rash, hyperglycemia, and diarrhea.

While the FDA is not legally bound by the ODAC’s recommendation, the favorable vote significantly clears the path for a potential supplemental New Drug Application (sNDA) approval.

A similar regulatory application is currently under review in the European Union.

If approved, Truqap would become the first and only targeted treatment option specifically indicated for this biomarker-defined prostate cancer population.