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Amgen's Imdelltra Receives Accelerated FDA Approval for Advanced Small Cell Lung Cancer
May 17, 2024, 12:16 AM
Amgen has received accelerated approval from the U.S. Food and Drug Administration (FDA) for its new lung cancer drug, Imdelltra, also known as tarlatamab. This innovative treatment is designed for adults with advanced small cell lung cancer (SCLC) that has worsened despite chemotherapy. Imdelltra is the first bispecific T cell engager (BiTE) therapy approved for extensive-stage small cell lung cancer (ES-SCLC). Clinical trials have demonstrated that the drug can reduce tumor growth and extend patients' lives. Analysts predict that Imdelltra could become a blockbuster seller for Amgen. The drug targets DLL3 and comes with a boxed warning for CRS & Icans.
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Revenue from Imdelltra exceeds $1 billion • 25%
Revenue from Imdelltra is $500 million to $1 billion • 25%
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Additional warnings issued • 33%
Restriction on use broadened • 33%
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