Zepzelca (lurbinectedin)

OrphanAdditional monitoring

Region: 🇪🇺 EU
Active substance: lurbinectedin
Company: Pharma Mar S.A.
Status: Authorised
Therapeutic area: Small Cell Lung Carcinoma
CHMP opinion: Thu 26 Mar 2026
EU approval: Fri 29 May 2026
Designations: Orphan, Additional monitoring
Application: EMEA/H/C/006673
ATC: L01XX69
Official record: www.ema.europa.eu

Indication

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.

Regulatory milestones

Fri 29 May 2026🇪🇺 EU approval (EC decision)

Zepzelca (lurbinectedin) approved in the EU

Marketing authorisation to Pharma Mar S.A.; Orphan, Additional monitoring · source

Thu 26 Mar 2026🇪🇺 CHMP positive opinion

Zepzelca (lurbinectedin): CHMP positive opinion

Pharma Mar S.A.; Orphan, Additional monitoring · source

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.