AstraZeneca (AZN) announced that the U.S. FDA's Oncologic Drugs Advisory Committee (ODAC) has recommended approval of Truqap in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC).
The committee voted 7-1, with one abiraterone subtype of prostate cancer associated with poor outcomes and limited treatment options. Patients often progress despite standard hormone-lowering therapies, underscoring the need for targeted approaches. Investigators noted that PTEN loss drives tumor growth through dysregulation of the PI3K/AKT pathway, contributing to rapid disease progression.
The CAPItello-281 trial showed a 19% reduction in the risk of radiographic disease progression or death with Truqap combination compared with abiraterone plus ADT and placebo (HR 0.81; 95% CI 0.66-0.98; p=0.034). Median radiographic progression-free survival improved to 33.2 months vs. 25.7 months in the control arm. Key secondary endpoints also favored the combination, including delayed castration resistance (29.5 vs. 22.0 months) and prolonged PSA progression. Overall survival data remain immature, with interim results numerically favoring Truqap.
The safety profile was consistent with known effects of AKT inhibition. Grade 3 or higher adverse events occurred in 67% of patients receiving the Truqap regimen versus 40.4% in the control group, with rash, hyperglycemia, hypokalemia, diarrhea, hypertension, and anemia among the most common events.
ODAC's recommendation will be considered by the FDA as it reviews AstraZeneca's supplemental New Drug Application. A regulatory submission for the same indication is also under review in the European Union.
AZN has traded between $132.32 and $212.71 over the past year. The stock closed Thursday's trading at $187.37, up 1.17%. In pre-market trading, the stock is at $186.41, down 0.56%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.