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Amgen Says FDA Granted Full Approval to Imdelltra to Treat Extensive Stage Small Cell Lung Cancer
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Amgen Says FDA Granted Full Approval to Imdelltra to Treat Extensive Stage Small Cell Lung Cancer
Nov 19, 2025 2:21 PM

04:52 PM EST, 11/19/2025 (MT Newswires) -- Amgen ( AMGN ) said Wednesday the US Food and Drug Administration has given full approval to Imdelltra, or tarlatamab-dlle, to treat adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

The company said the FDA's decision to convert Imdelltra's previous accelerated approval to a full approval is based on data from a phase 3 trial.

Also, the National Comprehensive Cancer Network's Clinical Practice Guidelines in Oncology have been updated to include tarlatamab as the only Category 1 preferred treatment option for adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy, the company said.

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