SVB Leerink analyst doesn’t expect cancer drug developed by Innovent and Lilly to be approved

Investors should expect to see fewer Food and Drug Administration approvals of copycat PD-L1 therapies after an advisory committee recommended against approving an experimental cancer drug, according to SVB Leerink analysts. The drug in question, sintilimab, is being developed by Innovent Biologics Inc. , a Chinese drug maker, and Eli Lilly & Co. . The FDA’s Oncologic Drugs Advisory Committee on Thursday voted against approving the drug as a frontline non-small cell lung cancer treatment; the main trial for the drug was conducted in China, and the committee said it wants additional studies assessing the therapy in the U.S. population. More broadly, the vote may be an indicator for how other copycat PD-L1 therapies will be viewed by U.S. regulators, the analysts said. “Were [the trial] a one-off case, we sense that the FDA may be more willing to grant approval, but given its status as a leading example, we believe the FDA will draw a line in the sand to discourage this single-country trial approach,” SVB Leerink analyst Daina Graybosch told investors on Friday. She also wrote that she does not expect sintilimab to receive FDA approval. Lilly’s stock was down 1.0% in trading on Friday and is up 17.0% over the past year. The S&P 500 has gained 15.2% over the past year.

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