Onco-Summaries: Daily Oncology Updates at a Glance

16/09/2025

Corbus and CSPC Pharma's CRB-701 ADC received the FDA Fast Track Designation for R/M HNSCC (Ref)

The US FDA granted the Fast Track Designation to Corbus Pharmaceuticals and CSPC Pharma's CRB-701 (Nectin-4 targeting ADC) for the treatment of R/M HNSCC previously treated with platinum-based chemo and an anti-PD(L)-1.

• Results from the dose optimization part of Phase 1/2 CRB-701-01/NCT06265727 trial will be presented at ESMO 2025

  
  

• Previously, the ADC received a Fast Track designation for R/R metastatic cervical cancer in Dec'24

  
  

• In Feb'23, Corbus had entered into an exclusive licensing agreement with CSPC Pharma for development and commercialization of CRB-701/SYS6002

  
  

  • Corbus gained rights to CRB-701 in the US, Canada, the EU, the UK, and Australia

    
    

  • CSPC retained all rights to SYS6002 in the remaining global markets