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 comments 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 comments 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 comments 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 comments 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.

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.