Lurbinectedin Medicine 03 June 2025 Extended 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. Therapeutic value No estimate possible yet Total cost € 32,080,000.00 Registration phase Positive CHMP opinion Product Active substance Lurbinectedin Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended 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. Current proprietary name Already available biosimilars / generics Proprietary name Zepzelca Manufacturer Pharma Mar Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Remmer van oncogene transcriptie; bindt aan de DNA-minder belangrijke groef en remt RNA polymerase II. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2025 Expected Registration June 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Sluice candidate Additional remarks Dossier (EMA) ingediend in juni 2025. FDA registratie voor lurbinectedine plus atezolizumab eerstelijns maintenance ES-SCLC is in behandeling - priority review toegekend in juni 2025. FDA heeft in juni 2020 een voorwaardelijke goedkeuring verleend voor lurbinectedine single agent in recidief SCLC. Positieve CHMP-opinie in maart 2026. Therapeutic value Current treatment options geen behandelingen Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is nog onduidelijk of het aan de CieBOM adviezen gaat voldoen. Atezolizumab heeft in Nederland geen indicatie voor SCLC. Duration of treatment Average 4 month / months Frequency of administration 1 times every 3 weeks Dosage per administration 3,2mg/m2 References NCT05091567 (IMforte); Paz-Ares et al. The Lancet. 2025. Additional remarks Expected patient volume per year Patient volume < 802 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 (1); Cramer-van der Welle et al. Eur J Cancer Care. 2020 (2). Additional remarks In 2021 waren er 1.637 SCLC diagnoses, waarvan 70% stadium 4 (1.146 patiënten) (1). 70% wordt behandeld in de eerstelijn (802 patiënten) (2). Expected cost per patient per year Cost € 30,000.00 - 50,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Afhankelijk van behandelduur. Deze is op dit moment onbekend. Om die reden op basis van andere indicaties van atezolizumab de inschatting gemaakt dat deze mogelijk €30.000 tot €50.000 per patiënt per jaar kan gaan kosten. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2026). Additional remarks Potential total cost per year Total cost € 32,080,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Clinicaltrials.gov Additional remarks Leyomiosarcoom. Fase 3 studie aan de gang. Other information Additional remarks