FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis

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  • Shaily Arora
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Sanjeeve Balasubramaniam
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Wei Zhang
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Lijun Zhang
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rajeshwari Sridhara
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Dianne Spillman
    2Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Jaigi P. Mathai
    3Health Canada, Ottawa, Ontario, Canada.
  • Bradley Scott
    3Health Canada, Ottawa, Ontario, Canada.
  • Sarah J. Golding
    4Therapeutic Goods Administration, Symonston, Australia.
  • Michael Coory
    4Therapeutic Goods Administration, Symonston, Australia.
  • Richard Pazdur
    2Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Julia A. Beaver
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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Description

<jats:title>Abstract</jats:title><jats:p>On September 17, 2019, FDA granted accelerated approval to pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. The submission and review of this application was conducted through an FDA Oncology Center of Excellence initiative named Project Orbis whereby the FDA, the Australian Therapeutic Goods Administration, and Health Canada were able to simultaneously review and collaborate, rendering simultaneous approval decisions in all countries. Accelerated approval of the pembrolizumab plus lenvatinib combination was based on a single-arm trial of 94 patients, with previously treated metastatic endometrial cancer whose tumors were not MSI-H/dMMR. Efficacy was demonstrated on the basis of an objective response rate of 38.3% (95% confidence interval, 28.5%–48.9%) with 10 complete responses (10.6%) accompanied by supportive durations of response. Trials to confirm clinical benefit of this combination are ongoing. Here, we summarize the benefit–risk analysis supporting accelerated approval of the pembrolizumab plus lenvatinib combination and describe the methodology for the first Project Orbis review.</jats:p>

Journal

  • Clinical Cancer Research

    Clinical Cancer Research 26 (19), 5062-5067, 2020-10-01

    American Association for Cancer Research (AACR)

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