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
"Small cell lung cancer is one of the most aggressive solid tumors, with high rates of relapse following first-line treatment and limited treatment options," said Jean-Charles Soria, senior vice president of Oncology at Amgen. "The European Commission's approval of IMDYLLTRA, the first and only T-cell engager therapy approved to treat small cell lung cancer, marks an important step forward for patients in Europe and reflects our commitment to advancing innovative medicines that can meaningfully improve outcomes for people living with this devastating disease."
