Onco-Summaries: Daily Oncology Updates at a Glance

23/06/2025

Datroway has been approved in the US for locally advanced or metastatic EGFR-mutated NSCLC (Ref)

• The US FDA approved AstraZeneca and Daiichi's datopotamab deruxtecan (Datroway; TROP2 ADC) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy.

  
  

  • The indication is approved under accelerated approval based on ORR and DoR results from a subgroup analysis of the Phase 2 TROPION-Lung05 trial and supported by data from the Phase 3 TROPION-Lung01 trial.

    
    

  • The approval follows a priority review and breakthrough therapy designation.

    
    

  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Daraxonrasib received the FDA Breakthrough Therapy Designation for previously treated metastatic pancreatic cancer with KRAS G12 mutations (Ref)

• The US FDA granted the Breakthrough Therapy Designation to Revolution Medicines' daraxonrasib (RAS(ON) multi-selective inhibitor) for previously treated metastatic PDAC in patients with KRAS G12 mutations.

  
  

  • The designation has been granted based on encouraging data from the Phase 1 RMC-6236-001 trial of daraxonrasib in patients with previously treated metastatic PDAC.

    
    

  • Revolution is currently conducting the Phase 3 RASolute 302 trial of daraxonrasib in patients with previously treated metastatic PDAC.

    
    

    • The study design focuses on a core population of patients with RAS G12X mutations, and an expanded population of patients RAS G12X, G13X or Q61X mutations, or those without any identified targetable mutation.

      
      

    • The dual primary endpoints for the study are PFS and OS in the core patient population.