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Regulatory Insights: Considerations in Seeking US FDA Oncology NDA/BLA Approval with Predominantly Asian Clinical Data

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With the vibrant new drug industry in China, many promising investigational new drugs are vying for approval in the commercially attractive US market. The unsuccessful example of the FDA Oncologic Drugs Advisory Committee meeting in February 2022 for sintilimab, for the BLA in first-line non-small cell lung cancer based on 100% Chinese data (ORIENT-11), serves as a cautionary tale for Chinese drug companies to plan thoroughly and carefully in designing/conducting clinical trials and engaging with the US FDA. In this article, we will address the specific US regulations and FDA/ICH guidance regarding the use of foreign clinical data as the sole basis of approval and showcase a few recent success stories.