Lurbinectedin

Extended indication	Small cell lung cancer (SCLC)
Therapeutic value	No estimate possible yet
Total cost	223,600,000.00
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 agent; binds to DNA minor groove and inhibits RNA polymerase II.

Registration

Registration route	Centralised (EMA)
Submission date	2022
Expected Registration	2023
Orphan drug	Yes
Registration phase	Clinical trials
Additional remarks	Priority review FDA, sinds feb 2020. Er is nog geen informatie over een indiening bij de EMA.

Therapeutic value

Therapeutic value	No estimate possible yet
Substantiation	Waarschijnlijk een product dat ingezet kan gaan worden als tweedelijns behandeling.
References	NCT02566993

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.

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

Cost	< 200,000.00
References	Drugs.com
Additional remarks	In de VS kosten 30 tabletten van 100 mg ongeveer $18.500 (€16.400). De behandelduur is momenteel onbekend maar bij behandeling van een jaar zouden de kosten neerkomen op ongeveer €200.000. Mogelijk zal de prijs in de EU lager uitvallen dan in de VS. Financieel grote impact gezien het bovenop de kosten komt voor doxorubicin.

Potential total cost per year

Total cost	223,600,000.00 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.

Total cost

223,600,000.00

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.

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 3 voor eierstokkanker, maar eindpunten niet gehaald.

Other information

There is currently no futher information available.