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The Path To Tarlatamab Approval: Leveraging Innovative Strategies and Global Regulatory Pathways
Vandana Pathak1, Claudia Arredondo Pimentel2, Elli Cooney1
1Global Regulatory Affairs (Oncology), Amgen Inc, Thousand Oaks, USA.
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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