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Letter to the Editor| Volume 169, P103-105, July 2022

Approved anti-PD-1 monoclonal antibodies in China: A bridge too far for US approval

      On 10th February 2022, the US Food and Drug Administration's (FDA) Oncologic Drug Advisory Committee (ODAC) convened to discuss the Biologic License Application (BLA) for sintilimab, an anti-PD-1 monoclonal antibody as initial treatment (with chemotherapy) for metastatic non-small cell lung cancer (NSCLC) [

      February 10, 2022: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 02/10/2022 | FDA n.d. https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-10-2022-meeting-oncologic-drugs-advisory-committee-meeting-announcement-02102022 (accessed March 9, 2022).

      ]. This BLA was based on the pivotal phase III ORIENT-11 trial conducted entirely in China (race/ethnicity 100% Asian) [
      • Yang Y.
      • Wang Z.
      • Fang J.
      • Yu Q.
      • Han B.
      • Cang S.
      • et al.
      Efficacy and safety of sintilimab plus pemetrexed and platinum as first-line treatment for locally advanced or metastatic nonsquamous NSCLC: a randomized, double-blind, phase 3 study (oncology pRogram by InnovENT anti-PD-1-11).
      ]. Although this drug approval was the primary focus for the ODAC meeting, the broader issue of the concept of generalisability and applicability of single-country foreign data to a US population was also explored.
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