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 .

Link : https://www.curetoday.com/view/fda-withdraws-zepzelca-approval-for-previously-treated-small-cell-lung-cancer

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withdrawn cancer accelerated approvals .

Link : https://www.curetoday.com/view/fda-withdraws-zepzelca-approval-for-previously-treated-small-cell-lung-cancer