Lilly-Innovent's Sintilimab Plus Chemo Application For Lung Cancer Under Review With FDA

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  • The FDA has accepted to review Innovent Biologics Inc IVBIY and Eli Lilly and Co's LLY marketing application for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC).
  • It is the first U.S. regulatory submission of sintilimab, a PD-1 inhibitor being developed and commercialized under a global collaboration agreement between Innovent and Lilly.
  • "We look forward to working closely with the FDA to potentially bring this sintilimab-pemetrexed-platinum chemotherapy combination as a treatment option in the U.S., following the regimen's regulatory approval in China earlier this year," said Dr. Yongjun Liu, president of Innovent.
  • Price Action: LLY shares closed at $195.53 on Monday.
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