Lurbinectedin Medicine 12 June 2018 Extended indication Small cell lung cancer (SCLC) Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Lurbinectedin Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Small cell lung cancer (SCLC) Current proprietary name Already available biosimilars / generics Proprietary name Zepsyre Manufacturer Pharma Mar Portfolio holder Mechanism of action Alkylating agent Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Alkylating agent; binds to DNA minor groove and inhibits RNA polymerase II. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration September 2021 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Waarschijnlijk een product dat ingezet kan gaan worden als 2e lijns behandeling. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 1,118 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2016 werden er 1.118 diagnoses stadium 4 SCLC geregistreerd. Expected cost per patient per year Cost References Additional remarks Financieel grote impact gezien het bovenop de kosten komt voor doxorubicin. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Clinicaltrials.gov Additional remarks Onderzocht in fase 3 voor eierstokkanker, maar eindpunten niet gehaald. Other information Additional remarks