The European Commission has granted marketing authorization for Zepzelca (lurbinectedin) in combination with atezolizumab as first-line maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC), marking the first approval of a combination maintenance regimen in this setting in Europe. The decision applies to patients whose disease has not progressed following induction therapy with atezolizumab, carboplatin, and etoposide. Sweden-based Immedica Pharma AB holds marketing authorization rights across the Nordics, UK and Ireland, Central Eastern Europe, and the Middle East and North Africa under a licensing agreement with Spain-based PharmaMar S.A., the drug’s originator.

The approval – which follows a positive CHMP opinion in March – rests on data from the Phase III IMforte trial, which evaluated lurbinectedin plus atezolizumab against atezolizumab maintenance alone following four cycles of induction chemoimmunotherapy. The combination reduced the risk of disease progression or death by 46% and the risk of death by 27% compared with atezolizumab monotherapy. Median overall survival was 13.2 months versus 10.6 months in the control arm (stratified hazard ratio 0.73; 95% CI: 0.57–0.95; p=0.0174), while median progression-free survival by independent assessment reached 5.4 months versus 2.1 months (stratified HR=0.54; 95% CI: 0.43–0.67; p < 0.0001). Safety was described as consistent with the established profiles of both agents. The results were presented at the 2025 American Society of Clinical Oncology annual meeting and published simultaneously in The Lancet. The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion in March 2026, preceding the Commission’s formal decision.

Lurbinectedin is a synthetic analogue of the marine-derived compound trabectedin, functioning as a selective inhibitor of oncogenic transcription programs on which tumor cells are particularly dependent. Beyond its direct effect on cancer cells, lurbinectedin also inhibits oncogenic transcription in tumor-associated macrophages, suppressing cytokine production that supports tumor growth — a mechanism that may complement the immune checkpoint activity of atezolizumab, a PD-L1 inhibitor. ES-SCLC is characterized by rapid relapse after initial response, and the combination’s dual targeting of transcriptional addiction and immune evasion provides a biological rationale for the maintenance strategy. The drug was first globally approved in the US in 2020, developed by Jazz Pharmaceuticals.

EU approval positions lurbinectedin plus atezolizumab within a competitive but still narrow field for ES-SCLC maintenance. AstraZeneca’s Imfinzi (durvalumab), approved by the US FDA in March 2020 based on the CASPIAN trial, is the closest structural comparator — it is used as single-agent maintenance following a PD-L1 inhibitor-based induction regimen, representing the prior benchmark against which combination maintenance approaches are assessed. More recently, Amgen’s Imdelltra (tarlatamab-dlle), a bispecific T-cell engager targeting DLL3 and CD3, received traditional US FDA approval in November 2025 for ES-SCLC after platinum-based chemotherapy progression, and also gained EU approval this week. The lurbinectedin combination is the first regimen to demonstrate an overall survival benefit in a dedicated 1L maintenance trial in ES-SCLC.

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