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FDA advisors caution against sintilimab approval in US

The FDA advisory committee has cautioned the drug regulator that sintilimab should not be approved for advanced lung cancer until additional study demonstrates applicability of the same to US patients. The biologic drug, developed by Innovent Biologics and Eli Lilly, has been approved in China, based on results of the randomised phase 3 ORIENT-11 study — conducted exclusively in China, showing the addition of the agent to chemotherapy prolonged PFS (progression-free survival) among patients with locally advanced or metastatic nonsquamous non-small cell lung cancer.

Content by Future Medicine

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