AZN · AstraZeneca PLC

The FDA Oncologic Drugs Advisory Committee (ODAC) provided a strong endorsement for AstraZeneca's Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), voting 7 to 1 with one abstention. This recommendation stems from the CAPItello-281 Phase III trial, the first pivotal study prospectively defining this aggressive subtype affecting one in four mHSPC patients. Key trial results include a statistically significant 19% reduction in risk of radiographic progression or death (HR 0.81; 95% CI 0.66-0.98; p=0.034), extending median rPFS from 25.7 months in the control arm to 33.2 months. Secondary endpoints reinforced efficacy with prolonged time to castration resistance (HR 0.77) and PSA progression (HR 0.73), alongside trends in skeletal event-free survival and immature OS data favoring the combination. While Grade 3+ adverse events were higher (67% vs 40.4%), common events like rash and hyperglycemia align with Truqap's known profile. This positions Truqap as the first targeted therapy for this high-unmet-need population, following sNDA acceptance in August 2025 and ongoing EU review. The FDA will consider but is not bound by ODAC's advice, potentially accelerating approval and expanding AstraZeneca's oncology portfolio beyond its breast cancer indication.