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U.S. Food and Drug Administration Analysis of Newly Identified Adverse Events With Lurbinectedin: Extravasation, Rhabdomyolysis, and Tumor Lysis Syndrome

  • David A. Kaland
    Correspondence
    Address for correspondence: David A. Kaland, PharmD, BCOP, Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993
    Affiliations
    Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, MD
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  • Graça M. Dores
    Affiliations
    Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, MD
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  • Afrouz Nayernama
    Affiliations
    Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, MD
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  • Sara Camilli
    Affiliations
    Division of Pharmacovigilance, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, Silver Spring, MD
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Published:August 29, 2022DOI:https://doi.org/10.1016/j.cllc.2022.08.014

      Clinical Practice Points

      • Lurbinectedin is an intravenous alkylating drug approved by the U.S. Food and Drug Administration (FDA) under accelerated approval on June 15, 2020, for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
      • During routine pharmacovigilance monitoring, the FDA identified safety signals for new adverse events (AE)s with lurbinectedin: extravasation, rhabdomyolysis, and tumor lysis syndrome (TLS).
      • Further evaluation of these AEs led to their addition to the lurbinectedin U.S. prescribing information (USPI).
      • Clinicians should be aware of these safety issues and implement mitigation strategies to minimize the potential risk of these AEs.

      Keywords

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