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Reported June 1, 2026: European Commission Approves Amgen's IMDYLLTRA For The Treatment Of Extensive-Stage Small Cell Lung Cancer

Benzinga · 1d ago

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Approval Based Upon Phase 3 DeLLphi-304 Trial Demonstrating 40% Reduction in Risk of Death with IMDYLLTRA Compared to Chemotherapy

Novel Treatment Option for Patients with Extensive-Stage Small Cell Lung Cancer That Has Progressed

THOUSAND OAKS, Calif., June 1, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has granted marketing authorization for IMDYLLTRA® (tarlatamab) as a monotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.

The approval was based on results from DeLLphi-304, the first global Phase 3 trial to demonstrate a significant survival benefit over chemotherapy in this setting.1

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