Lurbinectedin

Active substance
Lurbinectedin
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Lung cancer
Extended indication
Small cell lung cancer (SCLC)

1. Product

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.

2. Registration

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

3. Therapeutic value

Therapeutic value
No judgement
Substantiation
Waarschijnlijk een product dat ingezet kan gaan worden als 2e lijns behandeling.
Duration of treatment
Not found

4. 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.

5. Expected cost per patient per year

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

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.