April 02, 2026
The European Medicines Agency (EMA) has recommended granting EU-wide marketing authorization for Imdylltra, a novel treatment for adults with relapsed extensive-stage small cell lung cancer (ES-SCLC). The therapy is intended for patients whose disease has progressed following platinum-based chemotherapy, a setting where treatment options remain limited and prognosis is poor.
Imdylltra contains tarlatamab, a bispecific antibody designed to engage the immune system by simultaneously binding to DLL3 on tumor cells and CD3 on T cells. This interaction brings immune cells into close proximity with cancer cells, triggering targeted cytotoxic activity and tumor cell destruction.
The EMA’s recommendation is based on a phase 3 randomized clinical trial involving 509 patients. Results demonstrated a significant improvement in median overall survival, reaching 13.6 months in patients treated with Imdylltra compared to 8.3 months with standard therapies such as topotecan or lurbinectedin, corresponding to a 40% reduction in mortality risk. Progression-free survival was also modestly improved.
Safety data identified cytokine release syndrome and immune-related neurotoxicity as the most serious adverse events, requiring careful monitoring and management.
If approved by the European Commission, Imdylltra would represent a new class of targeted immunotherapy for relapsed ES-SCLC, addressing a critical unmet need and offering improved survival outcomes for patients with this highly aggressive cancer.
SOURCE: https://www.ema.europa.eu/en/news/new-treatment-relapsed-extensive-stage-small-cell-lung-cancer
CREDITS: EMA