Onco-Summaries: Daily Oncology Updates at a Glance

09/07/2025

Artera's ArteraAI Prostate received the Breakthrough Device designation from the US FDA (Ref)

• The US FDA granted the Breakthrough Device designation to Artera's ArteraAI Prostate (an AI precision medicine tool) intended to assist clinicians with risk-based decisions for patients with localized prostate cancer

  
  

  • ArteraAI Prostate analyzes digital pathology images of the prostate cancer biopsy slide to prognosticate long-term outcomes, such as 10-yr risk of distant metastasis and prostate-cancer specific mortality, to help clinicians determine the most appropriate treatment option

    
    

  • Andre Esteva, CEO, Artera: "This designation is a powerful validation of our software's potential to transform how we treat cancer. We’re proud that the FDA has recognized our innovative technology platform, and we’re excited to be advancing the frontier of oncology by delivering differentiated and clinically relevant tools that can help save more lives."

Trethera Corporation's TRE-515 received the Fast Track Designation from the US FDA (Ref)

• The US FDA granted the Fast Track designation for Trethera Corporation's TRE-515 (dCK inhibitor) in the treatment of prostate cancer 

  
  

  • TRE-515 is currently in Phase 1 clinical trials for solid tumors

    
    

  • The designation applies to TRE-515 + radioligand therapy for the treatment of PSMA+ve metastatic castration resistant prostate cancer