FDA Advisory Committee Recommends TRUQAP for PTEN-Deficient Prostate Cancer
The FDA's Oncologic Drugs Advisory Committee has recommended AstraZeneca's TRUQAP (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for treating PTEN-deficient metastatic hormone-sensitive prostate cancer. The recommendation is based on the CAPItello-281 Phase III trial, which demonstrated a favorable benefit-risk profile for the drug combination. The trial showed a significant reduction in the risk of disease progression and improved survival outcomes for patients. This marks the first targeted treatment combination to show benefits in this specific subtype of prostate cancer, addressing a significant unmet need for patients with limited treatment options.