mHSPC / mCSPC

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 […]

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 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 […]

Tempus AI has launched the ArteraAI Prostate Test (mHSPC), the first externally developed digital pathology algorithm integrated into the Tempus clinical ecosystem. The AI-powered, CLIA-certified assay combines histopathology, clinical data, and genomic insights to improve risk stratification and guide personalized therapy intensity decisions for patients with metastatic hormone-sensitive prostate cancer.

The Oncologic Drugs Advisory Committee (ODAC) voted 7 to 1, with one abstention, that the regimen demonstrated a favorable benefit-risk profile for AstraZeneca’s TRUQAP (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). The recommendation, based on results from the phase 3 CAPItello-281 trial, highlights […]

The combination of talazoparib (Talzenna) and enzalutamide (Xtandi) significantly improved radiographic progression-free survival (rPFS) in patients with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC) in the Phase III TALAPRO-3 trial. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of disease progression or death […]

FDA approves Akeega (niraparib + abiraterone acetate with prednisone) for BRCA2-mutated metastatic castration-sensitive prostate cancer, showing significant improvements in radiographic progression-free survival and delayed symptomatic progression, with a safety profile consistent with the individual therapies.