FDA Rejects Lilly's Sintilimab/Chemo Combo Therapy In First-Line Lung Cancer Setting

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The FDA sent a rejection letter to Eli Lilly And Co LLY regarding its anti-PD-1 antibody sintilimab for the first-line treatment of nonsquamous non-small cell lung cancer.

  • The complete response letter (CRL) follows a nearly unanimous Oncologic Drugs Advisory Committee (ODAC) recommendation against sintilimab's approval. 
  • The CRL includes a recommendation for an additional clinical study, specifically a multiregional clinical trial comparing standard of care therapy for first-line metastatic NSCLC to sintilimab with chemotherapy utilizing a non-inferiority design with an overall survival endpoint.
  • Read Next: Eli Lilly's Phase 3 Jardiance Study Stopped Early Due To Clear Positive Efficacy In Kidney Disease.
  • As far as the next steps for sintilimab, which is approved in China, Lilly said it's assessing the situation with Innovent Biologics Inc IVBXF on the U.S. market.
  • Price Action: LLY shares are up 0.84% at $286.57 during the market session on the last check Thursday.
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