Onco-Summaries: Daily Oncology Updates at a Glance

13/04/2026

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• FDA issues Complete Response Letter to Replimune’s RP1 BLA, halting accelerated approval path

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FDA issues Complete Response Letter to Replimune’s RP1 BLA, halting accelerated approval path (Ref)

Replimune received a Complete Response Letter (CRL) from the FDA rejecting its Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) + nivolumab in advanced Melanoma

• Regulatory Concerns:

  
  

  • FDA’s review process was inconsistent, with a new team replacing the prior reviewers.

  
  

  • Contradictions between earlier FDA guidance (accepting single-arm trial data for accelerated approval) and the CRL

  
  

  • Disputes over tumor assessment methodology despite Replimune following FDA’s requested RECIST 1.1 criteria

• Clinical Data (IGNYTE trial):

  
  

  • 34% response rate in patients progressing on prior anti-PD-1 therapy

  
  

  • Median response duration: 24.8 months

  
  

  • Median progression-free survival: 30.6 months in responders vs. 4.4 months on prior therapy

  
  

  • Favorable safety profile

• Impact:

  
  

  • Without accelerated approval, RP1 development is not viable

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