Extended indication Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL).
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Parsaclisib
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication Indolent non-Hodgkin’s lymphoma
Extended indication Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL).
Manufacturer Incyte
Portfolio holder Incyte
Mechanism of action Other, see general comments
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional comments Werkingsmechanisme: Antineoplastic agents, phosphatidylinositol-3-kinase (PI3K) inhibitors

Registration

Registration route Centralised (EMA)
Type of trajectory Conditional marketing authorisation
ATMP No
Submission date November 2021
Expected Registration January 2023
Orphan drug Yes
Registration phase Registration application pending
Additional comments Medicine under evaluation bij de EMA op basis van fase 2b studie (NCT03144674; CITADEL-204). Aanvraag bij de FDA voor deze indicatie is teruggetrokken in februari 2022.

Therapeutic value

Current treatment options Andere PI3K delta remmers zoals, umbralisib en copalisib.
Therapeutic value No estimate possible yet
Substantiation Uit de HOVON-richtlijn 2021 staat dat waar mogelijk patiënten met R/R MZL geïncludeerd moeten worden in studies, bijvoorbeeld met nieuwe vormen van immuuntherapie of ‘targeted drugs’. Er zijn nog geen gepubliceerde data uit de studie Ferero bekend.
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 20 mg eerste 8 weken, daarna 2,5 mg
References HOVON-richtlijn, Marginale Zone Lymfoom (2021) NCT03144674 (CITADEL-204, fase 2b) NCT04796922 (CITADEL-302, fase 3 icm folliculair lymfoom)

Expected patient volume per year

Patient volume

< 225

Market share is generally not included unless otherwise stated.

References HOVON-richtlijn MZL (2021) Horizonscan record umbralisib
Additional comments Ongeveer 10-15% van de Non Hodgkin Lymfoom gevallen is een marginale zone lymfoom. In Nederland zijn er 3.000 nieuwe patiënten per jaar. Hiervan zijn dus ongeveer 300 patiënten met marginale zone lymfoom. Naar verwachting zal 50% hiervan op enig moment een tweedelijnsbehandeling ondergaan. Het patiëntvolume zal daardoor maximaal 150-225 patiënten bedragen. Echter worden er beperkte patiëntaantallen verwacht gezien concurrerende geneesmiddelen.

Expected cost per patient per year

References medicijnkosten.nl
Additional comments Kosten per patiënt per jaar afhankelijk van ziekteprogressie of onaanvaardbare toxiciteit. Kosten idelalisib (Zydelig) €125 per dag (op basis van: 2xper dag)

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 Yes
Indication extensions Mantle Cell Lymphoma & Follicular lymphoma
References Mantle Cell Lymphoma (NCT03235544; fase 2 , NCT04849715; fase 3), Follicular lymphoma (NCT03126019; fase 2 & NCT04796922; fase 3 icm R/R MZL)
Additional comments CITADEL-203 (NCT03126019) is evaluating patients with relapsed or refractory follicular lymphoma (FL) Grade 1, 2 or 3a who received at least two prior systemic therapies, had an Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2, and were ineligible for hematopoietic stem cell transplantation (HSCT). CITADEL-205 (NCT03235544) is evaluating patients with relapsed or refractory mantle cell lymphoma (MCL), who received one to three prior systemic therapies and were either naive to or were previously treated with a BTK inhibitor. Eligible patients had an ECOG PS ≤2, and radiologically measurable lymphadenopathy or extranodal lymphoid malignancy.

Other information

There is currently no futher information available.