Behind the FDA approval of capivasertib for mHSPC, with Daniel J. George, MD
Daniel J. George, MD, discusses the clinical significance of the FDA approval of capivasertib, practical considerations for PTEN testing and toxicity management, and the broader implications of precision medicine for patients with advanced prostate cancer.
The treatment landscape for metastatic hormone-sensitive prostate cancer (mHSPC) continues to evolve with the incorporation of biomarker-driven therapeutic strategies. On June 12, 2026, the FDA approved capivasertib (Truqap) in combination with abiraterone acetate (Zytiga) and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously mHSPC, marking the first approved treatment specifically targeting this molecularly defined subset of disease.1,2 PTEN loss, which occurs in approximately one-quarter of patients with metastatic prostate cancer, is associated with activation of the PI3K/AKT signaling pathway and has long been recognized as a poor prognostic factor.