FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

  • Sonia Singh
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Adnan A. Jaigirdar
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Flora Mulkey
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Joyce Cheng
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Salaheldin S. Hamed
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Yangbing Li
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Jiang Liu
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Hong Zhao
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Anwar Goheer
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Whitney S. Helms
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Xing Wang
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rajiv Agarwal
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rajan Pragani
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kwadwo Korsah
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Shenghui Tang
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • John Leighton
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Atiqur Rahman
    1Center for Drug Evaluation and Research, 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.
  • Richard Pazdur
    2Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Marc R. Theoret
    2Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Harpreet Singh
    1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

抄録

<jats:title>Abstract</jats:title> <jats:p>On June 15, 2020, the FDA granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was granted on the basis of the clinically meaningful effects on overall response rate (ORR) and duration of response (DOR), and the safety profile observed in a multicenter, open-label, multicohort clinical trial (PM1183-B-005-14, NCT02454972), referred to as Study B-005, in patients with advanced solid tumors. The trial included a cohort of 105 patients with metastatic SCLC who had disease progression on or after platinum-based chemotherapy. The confirmed ORR determined by investigator assessment using RECIST 1.1 in the approved SCLC patient population was 35% [95% confidence interval (CI): 26–45], with a median DOR of 5.3 (95% CI: 4.1–6.4) months. The drug label includes warnings and precautions for myelosuppression, hepatotoxicity, and embryo-fetal toxicity. This is the first drug approved by the FDA in over 20 years in the second line for patients with metastatic SCLC. Importantly, this approval includes an indication for patients who have platinum-resistant disease, representing an area of particular unmet need.</jats:p>

収録刊行物

  • Clinical Cancer Research

    Clinical Cancer Research 27 (9), 2378-2382, 2020-12-07

    American Association for Cancer Research (AACR)

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