Zepzelca

Oncology· 1323 cited findings· 1 source document

Company: Mar S A

What the regulatory reviews say

Zepzelca, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. It has been granted New Active Substance status and Orphan Designation (EU/3/19/2143, granted 26 Feb 2019) by the EMA.

Key efficacy findings include a median Progression-Free Survival (PFS) of 5.36 months and a median Overall Survival (OS) of 13.2 months. The maximal Objective Response Rate (ORR) observed was 69.1%. The recommended starting dose for Zepzelca is 3.2 mg/m², with dose reductions specified for hepatic impairment or CYP3A inhibitors (1.6 mg/m²).

Notable safety findings include a decreased platelet count incidence of 15.3% and a decreased neutrophil count incidence of 13.2% in the Lurbinectedin arm. Decreased appetite incidence was 18.2% in the Lurbinectedin arm.

Key figures — cited to the source page

Median PFS	5.36	Mar S A — Zepzelca EMA EPAR public assessment report (EMEA/H, p.80
Median OS	13.2	Mar S A — Zepzelca EMA EPAR public assessment report (EMEA/H, p.80
Maximal ORR	69.1%	Mar S A — Zepzelca EMA EPAR public assessment report (EMEA/H, p.92
Recommended starting dose	3.2 mg/m2	Mar S A — Zepzelca EMA EPAR public assessment report (EMEA/H, p.19
Dose reduction for hepatic impairment or CYP3A inhibitors	1.6 mg/m2	Mar S A — Zepzelca EMA EPAR public assessment report (EMEA/H, p.19
Platelet count decreased incidence (Lurbinectedin arm)	15.3 %	Mar S A — Zepzelca EMA EPAR public assessment report (EMEA/H, p.147
Neutrophil count decreased incidence (Lurbinectedin arm)	13.2 %	Mar S A — Zepzelca EMA EPAR public assessment report (EMEA/H, p.147
Orphan designation number	EU/3/19/2143	Mar S A — Zepzelca EMA EPAR public assessment report (EMEA/H, p.11

Source documents

Mar S A — Zepzelca EMA EPAR public assessment report (EMEA/H/C/006673, 2026) (2026)

Explore the full evidence

All 1323 cited findings for Zepzelca — searchable, comparable and answerable in plain language — are in the Oncology research library →

Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.