Onco-Summaries: Daily Oncology Updates at a Glance

22/07/2025

Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA (Ref)

The US FDA issued a Complete Response Letter (CRL) regarding the BLA for Replimune's vusolimogene oderparepvec (RP1; herpes simplex virus engineered with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivolumab for the treatment of advanced melanoma. The CRL highlighted that the FDA was unable to approve the application in its present form due to the following reasons:

• The Ph1/2 IGNYTE trial was not considered to be an adequate and well-controlled clinical investigation that provided substantial evidence of effectiveness

  
  

• The trial could not be adequately interpreted due to the heterogeneity of the patient population

  
  

• There were items related to the confirmatory trial design which need to be addressed, including contribution of components

  
  

• To note, no safety issues were raised