Zepzelca

Opinion

EMA has issued an opinion on this medicine

lurbinectedin

Overview

On 26 March 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zepzelca, intended for the treatment of extensive-stage small cell lung cancer (ES-SCLC).

The applicant for this medicinal product is Pharma Mar S.A.

Zepzelca will be available as a 2 mg and 4 mg powder for concentrate for solution for infusion. The active substance of Zepzelca is lurbinectedin, an antineoplastic agent (ATC code: L01XX69). Lurbinectedin inhibits the oncogenic transcription process by binding to CG-rich DNA sequences, evicting transcription factors from their binding sites and stalling elongating RNA polymerase II and its specific degradation by the ubiquitin/proteasome machinery, which leads to cell cycle arrest and tumour cell apoptosis.

The benefits of Zepzelca as maintenance treatment in combination with atezolizumab in patients with ES-SCLC whose disease had not progressed after induction therapy are improved progression-free survival (PFS) and overall survival (OS), compared with maintenance treatment with atezolizumab alone. The most common side effects of Zepzelca are nausea, fatigue, anaemia, thrombocytopenia, and neutropenia.

The full indication is:

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.

Zepzelca therapy should be initiated and supervised by health professionals experienced in the use of anticancer products.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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Note: This product was designated as an orphan medicine during its development. EMA has reviewed the information available to date and determined that the orphan designation should be maintained

CHMP summary of positive opinion for Zepzelca

Adopted Reference Number: EMA/56282/2026

Product details

• Name of medicine:
  Zepzelca
• Active substance:
  lurbinectedin
• International non-proprietary name (INN) or common name:
  lurbinectedin
• Therapeutic area (MeSH):
  Small Cell Lung Carcinoma
• Anatomical therapeutic chemical (ATC) code:
  L01XX69
• EMA product number:
  EMEA/H/C/006673
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation applicant:
  Pharma Mar S.A.
• Opinion adopted:
  26/03/2026
• Opinion status:
  Positive