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<p>On May 16, 2024, tarlatamab-dlle (IMDELLTRA<sup>®</sup>) received approval as the first FDA DLL3 targeting bispecific T-cell engager (BiTE<sup>®</sup>) therapy indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression on or after platinum-based chemotherapy. This case study provides insights into the regulatory mechanisms, including global expedited pathways, special designations, and US FDA’s Oncology Center of Excellence initiatives, which played a key role in the expedited development, review, and approval of the tarlatamab marketing authorization application (MAA) globally.</p>

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The Path To Tarlatamab Approval: Leveraging Innovative Strategies and Global Regulatory Pathways

  • 期刊论文

  • 发表日期：

    2025年5月26日

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  • Vandana Pathak,
  • Claudia Arredondo Pimentel,
  • Elli Cooney,
  • Brian Abbott,
  • Jacqueline M. Kline

摘要

On May 16, 2024, tarlatamab-dlle (IMDELLTRA®) received approval as the first FDA DLL3 targeting bispecific T-cell engager (BiTE®) therapy indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression on or after platinum-based chemotherapy. This case study provides insights into the regulatory mechanisms, including global expedited pathways, special designations, and US FDA’s Oncology Center of Excellence initiatives, which played a key role in the expedited development, review, and approval of the tarlatamab marketing authorization application (MAA) globally.