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Tafasitamab

Minjuvi

Extended indication Tafasitamab in combinatie met lenalidomide is geïndiceerd in combinatie met rituximab, cyclofosfamid
Therapeutic value Possibly no place in the treatment regimen
Registration phase Clinical trials

Product

Active substance Tafasitamab
Domain Hematology
Reason of inclusion Indication extension
Main indication Aggressive non-Hodgkin’s lymphoma
Extended indication Tafasitamab in combinatie met lenalidomide is geïndiceerd in combinatie met rituximab, cyclofosfamide, doxorubicine, vincristine en prednison (R-CHOP) voor de behandeling van volwassen patiënten met onbehandeld diffuus grootcellig B-cellymfoom (DLBCL).
Proprietary name Minjuvi
Manufacturer Incyte
Portfolio holder Incyte
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Powder for solution for infusion
Budgetting framework Intermural (MSZ)
Centre of expertise EMC, AmsterdamUMC, RadBOUD UMC, UMCU, MUMC, UMCG.
Additional remarks Tafasitamab is een gehumaniseerd CD19-specifiek monoklonaal antilichaam van de immunoglobuline G (IgG)-subklasse geproduceerd in zoogdiercellen (ovariumcellen van de Chinese hamster) met behulp van recombinant-DNA-technologie

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2025
Expected Registration September 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks FRONTMIND: a Phase III, randomized, double-blind study of tafasitamab + lenalidomide + R-CHOP VS R-CHOP alone for newly diagnosed high-intermediate and high-risk diffuse large B-cell lymphoma .

Therapeutic value

Current treatment options Stadium I/II beperkt , zonder bulk, < 60 jaar en aaIPI 0 4x R-CHOP21 + 2R of 3x R-CHOP21 + involved node radiotherapie Stadium I/II beperkt, zonder bulk, alle leeftijden, PET-gestuurd 4x R-CHOP21 (indien iPET negatief) of 3x R-CHOP21 + involved node radiotherapie Stadium I/II beperkt, bulk Bij patiënten met bulk wordt aangeraden te behandelen als een stadium 2-4 ziekte middels 6x R-CHOP21 Stadium II-IV,Geen double of triple hit lymfoom 6x R-CHOP21 (+ 2R) Alternatief: 6x R-CHOP14 (+ 2R) Double en triple hit HGBL (DH/TH HGBL): 1x R-CHOP 21 en 5x DA-EPOCH-R met CNS profylaxe (of 6x DA-EPOCH-R indien bij diagnose DH/TH bekend is) of –6 x R-CHOP met lenalidomide (R2CHOP) met CNS profylaxe Alternatief: 6x R-CHOP21 met CNS profylaxe
Therapeutic value Possibly no place in the treatment regimen
Substantiation Er loopt een fase 3 studie (frontMIND). De werkgroep schat in dat dit middel voor deze indicatie geen plaats in de behandeling gaat krijgen.
Duration of treatment Not found
Frequency of administration 3 times every 3 weeks
Dosage per administration 12 mg per kg body weight
References https://publicatie.hematologienederland.nl/richtlijnen/diffuus-grootcellig-b-cel-non-hodgkin-lymfoom/. NCT05455697. https://clinicaltrials.gov/study/NCT05455697?cond=Follicular%20Lymphoma%20&intr=tafasitamab&rank=2.
Additional remarks Treatment consists of tafasitamab plus lenalidomide in addition to R-CHOP for six (6), 21-day cycles. Each 21-day cycle (cycles 1-6) will comprise of a tafasitamab intravenous (IV) infusion on Day 1, Day 8 and Day 15. Lenalidomide dose: Patients will self-administer a starting dose of 25 mg oral lenalidomide daily on Days 1–10 of each 21-day cycle. If needed, lenalidomide may be started on day 2 of each cycle and should be given for a maximum of 10 days but completed no later than day 15 (in case of interruptions).

Expected patient volume per year

Patient volume

< 0

Market share is generally not included unless otherwise stated.
References Expertopinie
Additional remarks De werkgroep schat in dat dit middel voor deze indicatie geen plaats in de behandeling gaat krijgen.

Expected cost per patient per year

References G-Standaard Z-Index
Additional remarks Minjuvi® flacon 200mg poeder voor concentraat voor oplossing voor infusie: €782

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.