Extended indication Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma, 2L
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Duvelisib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication CLL
Extended indication Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma, 2L
Proprietary name Copiktra
Manufacturer Verastem
Mechanism of action Serine / threonine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional comments Selective PI3K δ/γ inhibitor

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug Yes
Registration phase Clinical trials
Additional comments DUO trial: improved progression free survival (PFS).

Therapeutic value

Therapeutic value No judgement
Substantiation Momenteel te weinig informatie beschikbaar voor opname in de richtlijn.
Frequency of administration 2 times a day
Dosage per administration 25 mg
References NCT02004522
Additional comments De werkgroep ziet voorlopig geen indicatie voor duvelisib.

Expected patient volume per year

References NKR
Additional comments Aantal diagnoses CLL en SLL in 2016: 781 en 139 respectievelijk. Nog te weinig bekend over de mogelijke plaatsbepaling om een goede inschatting te kunnen doen van het patiëntvolume.

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 SPS

Other information

There is currently no futher information available.