Mar S A — Zepzelca EMA EPAR public assessment report (EMEA/H/C/006673, 2026)
Mar S A · 2026 · EMA EPAR public assessment report
Report summary
The EMA's assessment of Zepzelca (lurbinectedin) for extensive-stage small cell lung cancer (ES-SCLC) maintenance treatment, in combination with atezolizumab, resulted in a positive marketing authorization opinion on March 26, 2026. Despite an initial denial of accelerated assessment due to insufficient efficacy evidence and a more burdensome safety profile, the Phase 3 IMforte study demonstrated statistically significant improvements in progression-free survival and overall survival for the combination arm. While the combination increased adverse events, particularly hematologic and infectious toxicities, the benefit-risk balance was deemed positive. The report details Zepzelca's pharmaceutical development, non-clinical and clinical pharmacology, including its pharmacokinetic profile, and comprehensive safety data.
Key findings — cited to the page
| incidence of grade 4 neutropenia | 20% | · p.84 |
| increase in incidence of AE Grade 3-5 and AESI with increasing atezolizumab exposure | No significant increase | IMforte Arm A · p.80 |
| Neutrophil count decreased (Grade 3-4, aged ≥65, atezolizumab + lurbinectedin vs control) | 8.1 % | · p.167 |
| Thrombocytopenia (Grade 3-4, aged ≥65, lurbinectedin mono pool) | 4.9 % | · p.167 |
| ALT increase Grade ≥3 | 2.5 % | IMforte · p.184 |
| AST increase Grade ≥3 | 1.2 % | IMforte · p.184 |
| Thrombocytopenia (Grade 3-4, aged ≥65, atezolizumab + lurbinectedin vs control) | 4.8 % | · p.167 |
| Platelet count decreased (Grade 3-4, aged ≥65, atezolizumab + lurbinectedin vs control) | 8.1 % | · p.167 |
| Anaemia (Grade 3-4, aged ≥65, lurbinectedin mono pool) | 17.0 % | · p.167 |
| Neutropenia (Grade 3-4, aged ≥65, lurbinectedin mono pool) | 22.0 % | · p.167 |
| Febrile neutropenia (Grade 3-4, aged ≥65, atezolizumab + lurbinectedin vs control) | 1.6 % | · p.167 |
| randomized participants received prophylactic cranial irradiation (PCI) prior to randomization | 14.7 % | · p.117 |
Source: Mar S A ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →