🔔 Both ES-SCLC treatments flagged at CHMP in March have now received full European Commission marketing authorization, moving from positive opinion to formal EU approval.
These additions are clinically meaningful in a disease that remains aggressive, relapses early, and has historically offered patients few options after first-line platinum-based chemotherapy.
⭕ Tarlatamab by
@Amgen
This is the first DLL3-targeting bispecific T-cell engager authorized for SCLC in the EU. Approved now as monotherapy for adults with ES-SCLC requiring systemic therapy after progression on or after first-line platinum-based chemotherapy. In the Phase 3 DeLLphi-304 trial, tarlatamab reduced the risk of death by 40% versus standard-of-care chemotherapy (median OS 13.6 vs 8.3 months).
CRS and ICANS are recognized risks, so step-up dosing and monitoring in an appropriate care setting are required.
⭕ Lurbinectedin by
@PhrmMar
Approved in combination with atezolizumab (
@Roche) as first-line maintenance for adults with ES-SCLC whose disease has not progressed after induction with atezolizumab, carboplatin and etoposide. In the Phase 3 IMforte trial, the combination reduced the risk of progression or death by 46% and the risk of death by 27% versus atezolizumab alone (median OS 13.2 vs 10.6 months; median PFS 5.4 vs 2.1 months).
Together, these approvals address two distinct points in the ES-SCLC treatment pathway: first-line maintenance and the relapsed/progressed setting – gradually building out a new therapeutic landscape.