FDA AdComm Votes Against Lilly's Lung Cancer Drug, Sintilimab

The FDA advisory committee voted against the full approval of Eli Lilly And Co's LLY lung cancer treatment over concerns that the clinical trial was conducted only in China and that its results did not apply to U.S. patients.

• The monoclonal antibody treatment sintilimab injection combined with pemetrexed and platinum chemotherapy is for the first-line treatment of people with non-squamous non-small cell lung cancer. 
• Sintilimab is jointly developed by Lilly and its Chinese partner Innovent Biologics Inc IVBIY.
• The drug is already approved in China under the brand name Tyvyt.
• The panel further urged Lilly and Innovent Biologics to conduct additional clinical trials for FDA to approve the lung cancer immunotherapy.
• Meanwhile, responding to the FDA panel decision, Lilly said it was "disappointed" with the outcome of the advisory panel meeting but would continue to work with the FDA as the agency completes its review of sintilimab.
• "We have long-standing initiatives in place to advance diversity and inclusion in Lilly-conducted clinical trials," it said in a statement.."
• Price Action: LLY shares are trading 1.54% lower at $235.96 during the market session on the last check Friday.