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AstraZeneca’s Imfinzi Approved in EU for Limited-Stage Small Cell Lung Cancer

Imfinzi becomes the first immunotherapy approved in the EU for LS-SCLC, improving survival rates in a high-risk patient group.

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  • Mar 18, 2025

  • Mrudula Kulkarni

AstraZeneca’s Imfinzi Approved in EU for Limited-Stage Small Cell Lung Cancer

AstraZeneca’s Imfinzi (durvalumab) has been granted approval in the European Union as a monotherapy for adults with limited-stage small cell lung cancer (LS-SCLC) following successful platinum-based chemoradiation therapy (CRT). This decision by the European Commission is backed by data from the ADRIATIC Phase III trial, which demonstrated a 27% reduction in the risk of death compared to placebo. The study also showed that 57% of patients treated with Imfinzi were still alive at three years, marking a major milestone in a disease where survival rates remain low.

With LS-SCLC being an aggressive and rapidly progressing cancer, this approval represents a long-awaited advancement for European patients. As the first immunotherapy approved for both early- and late-stage SCLC, Imfinzi is set to reshape treatment paradigms. AstraZeneca continues to expand its global reach, with regulatory applications for Imfinzi currently under review in Japan and other regions.

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