Extended indication Small cell lung cancer (SCLC)
Therapeutic value No judgement
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)
Proprietary name Zepsyre
Manufacturer Pharma Mar
Mechanism of action Alkylating agent
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Alkylating agant; binds to DNA minor groove and inhibits RNA polymerase II.

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

Patient volume

< 1,118

Market share is generally not included unless otherwise stated.

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

Expected cost per patient per year

There is currently nothing known about the expected cost.

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 remarks Onderzocht in fase III voor eierstokkanker, maar eindpunten niet gehaald.

Other information

There is currently no futher information available.