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Review
. 2025 Sep;59(5):963-970.
doi: 10.1007/s43441-025-00809-8. Epub 2025 May 26.

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

Vandana Pathak  1 , Claudia Arredondo Pimentel  2 , Elli Cooney  1 , Brian Abbott  1 , Jacqueline M Kline  1
Affiliations
Review

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

Vandana Pathak et al. Ther Innov Regul Sci. 2025 Sep.

Abstract

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.

Keywords: Expedited regulatory pathways; Marketing authorization application; Project confirm; Project optimus; Project orbis; Regulatory approval; Tarlatamab.

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Conflict of interest statement

Declarations. Competing Interests: The authors declare no competing interests.

References

    1. Imdelltra (tarlatamab-dlle) Prescribing Information. Amgen 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf
    1. Rudin CM, Brambilla E, Faivre-Finn C, Sage J. Small-cell lung cancer. Nat Rev Dis Primers. 2021;7:3.
    1. American Cancer Society. Cancer Facts & Figs. 2022. American Cancer Society, GA, USA (2022).
    1. NCCN Clinical Practice. Guidelines in Oncology (NCCN GuidelinesⓇ) for Small Cell Lung cancer V.3.2025.
    1. Guidelines for Diagnosis and Treatment of Lung Cancer in Japan. 2021. https://www.haigan.gr.jp/guideline/2021/

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