Extended indication Small cell lung cancer (SCLC)
Therapeutic value No judgement
Registration phase Clinical trials


Active substance Lurbinectedin
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication Small cell lung cancer (SCLC)
Proprietary name Zepsyre
Manufacturer Pharma Mar
Mechanism of action Alkylating agent
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Alkylating agent; binds to DNA minor groove and inhibits RNA polymerase II.


Registration route Centralised (EMA)
Submission date 2020
Expected Registration September 2021
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Substantiation Waarschijnlijk een product dat ingezet kan gaan worden als 2e lijns behandeling.

Expected patient volume per year

Patient volume

< 1,118

Market share is generally not included unless otherwise stated.

References NKR
Additional comments In 2016 werden er 1.118 diagnoses stadium 4 SCLC geregistreerd.

Expected cost per patient per year

Additional comments Financieel grote impact gezien het bovenop de kosten komt voor doxorubicin.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References Clinicaltrials.gov
Additional comments Onderzocht in fase 3 voor eierstokkanker, maar eindpunten niet gehaald.

Other information

There is currently no futher information available.