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

IF 1.9 4区医学 Q4 MEDICAL INFORMATICS

Therapeutic innovation & regulatory science Pub Date : 2025-09-01 Epub Date: 2025-05-26 DOI:10.1007/s43441-025-00809-8

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

引用次数: 0

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.

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塔拉塔单抗获批之路：利用创新战略和全球监管途径。

2024年5月16日，tarlatamab-dlle （IMDELLTRA®）获得FDA批准，成为首个DLL3靶向双特异性t细胞参与器（BiTE®）治疗药物，用于治疗在铂基化疗期间或之后出现疾病进展的成人广泛期小细胞肺癌（ES-SCLC）。本案例研究提供了对监管机制的见解，包括全球加速途径、特殊指定和美国FDA肿瘤卓越中心计划，这些计划在全球加速开发、审查和批准塔拉他单抗上市许可申请（MAA）中发挥了关键作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY

CiteScore

3.40

自引率

13.30%

发文量

127

期刊介绍： Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations