EC approval for Amgen’s Imdylltra

2 June 2026

US biotech major Amgen (Nasdaq: AMGN) yesterday 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 III trial to demonstrate a significant survival benefit over chemotherapy in this setting.

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