16 octubre 2026

EMERGE 402 ( NO ES UN ENSAYO COMPARATIVO ) EVIDENCIA RESPUESTAS MODESTAS, PERO NO LOGRA BORRAR EL FRACASO DE LA FASE III LAGOON NI EVITAR LA RETIRADA DE SU APROBACIÓN POR LA FDA EN SEGUNDA LÍNEA : ACTIVIDAD ANTITUMORAL SIN BENEFICIO DE SUPERVIVENCIA CONFIRMADO .




ZEPZELCA ( LURBINECTEDIN ) US UPDATE-EXTENSIVE SMALL CELL LUNG CANCER EXTENSIVE-STAGE ( SCLC-ES ) :


FDA withdrew the accelerated approval for
2nd-line metastatic SCLC on 09/30/26 after the
confirmatory Phase III LAGOON trial failed to
meet OS (8.7 mo lurbinectedin mono vs 10.7
mo physician's choice topotecan/irinotecan)
Real-world Phase IV data from EMERGE 402
(n=267, including ECOG PS ≥2, CNS mets,
platinum-resistant, >2L) show consistent
activity - ORR 29%, mPFS 3.3 mo, moS 7.6 mo,
with few TRAE-related dose reductions/
discontinuations - but as a single-arm study it cannot override a negative randomized trial and does not change FDA withdrawal .

Approval that remainsb : 1L maintenance
LURBINECTEDIN + ATEZOLIZUMAB for ES-SCLC
without progression after induction
carboplatin/etoposide/atezolizumab(IMforte),
FDA approved Oct 2025 .

Refs : CURE Today Sept 30 2026, FDA list of
withdrawn cancer accelerated approvals .




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