FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer

FDA

19 November 2025 - Today, the FDA granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. 

Tarlatamab-dlle received accelerated approval for this indication in 2024.

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US , Dossier , Registration