The U.S. Food and Drug Administration (FDA) approved talazoparib (Talzenna, Pfizer Inc.) in combination with enzalutamide on October 26, 2026, for the treatment of adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer harboring homologous recombination repair (HRR) gene mutations, as detected by an FDA-authorized test. The approval was supported by data from […]
Vir Biotechnology announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VIR-5500, an investigational prostate-specific membrane antigen (PSMA)-targeted PRO-XTEN® dual-masked T-cell engager (TCE), for the treatment of late-line metastatic castration-resistant prostate cancer (mCRPC). The designation, which is intended to facilitate and expedite the development and review of drugs addressing […]
A post hoc exploratory analysis of the phase 3 PROpel trial, published in European Urology Oncology, reports efficacy, safety, and health-related quality of life (HRQoL) outcomes for olaparib plus abiraterone with prednisone/prednisolone versus placebo plus abiraterone with prednisone/prednisolone in the subgroup of patients with metastatic castration-resistant prostate cancer (mCRPC) who do not harbor BRCA1 or […]
Five-year patient-reported outcome data from NRG Oncology GU003, a phase 3 randomized trial, were presented at the ASTRO 2026 Annual Meeting by Mark Buyyounouski, MD, of Stanford University. The trial compared hypofractionated postprostatectomy radiotherapy (HYPORT) with conventionally fractionated postprostatectomy radiotherapy (COPORT) in men with high-risk prostate cancer features following radical prostatectomy. At five years, no […]
The FDA has expanded Pluvicto’s indication to include PSMA-positive metastatic hormone-sensitive prostate cancer in combination with an ARPI. Backed by the Phase III PSMAddition trial, the approval brings radioligand therapy into an earlier stage of prostate cancer treatment.
The FDA has approved capivasertib (Truqap) plus abiraterone and prednisone as the first targeted therapy for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer. CAPItello-281 demonstrated a 7.5-month improvement in radiographic progression-free survival, establishing a new biomarker-driven treatment option.
The phase 3 PROTEUS trial has achieved a landmark breakthrough in high-risk localized prostate cancer treatment, becoming the first study to demonstrate that perioperative systemic therapy combined with radical prostatectomy significantly improves both short- and long-term outcomes. The addition of apalutamide to androgen deprivation therapy (ADT) before and after surgery met both dual primary endpoints, […]
The ENZAMET trial represents a landmark achievement in prostate cancer research, demonstrating significant survival benefits for men with metastatic hormone-sensitive prostate cancer (mHSPC). This international phase III study, led by ANZUP in collaboration with the NHMRC Clinical Trials Centre, established enzalutamide as an important addition to first-line androgen deprivation therapy (ADT), showing improved outcomes compared […]