Extended indication Is indicated in combination with lenalidomide followed by monotherapy for the treatment of adult pat
Therapeutic value Possible added value
Registration phase Registration application pending

Product

Active substance Tafasitamab
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Aggressive non-Hodgkin's lymphoma
Extended indication Is indicated in combination with lenalidomide followed by monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).
Manufacturer MorphoSys
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Powder for solution for infusion
Budgetting framework Intermural (MSZ)
Additional comments Antibody-dependent cell cytotoxicity; CD19 antigen inhibitors.

Registration

Registration route Centralised (EMA)
Particularity New medicine with Priority Medicines (PRIME)
Submission date May 2020
Expected Registration June 2021
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options De behandeling voor DLBCL bestaat uit chemotherapie in combinatie met een antilichaam tegen CD20, in de derde lijn is CAR-T een optie.
Therapeutic value Possible added value
Substantiation In een fase 2 studie bij patiënten met relapsed/refractory DLBCL na 1-3 eerdere lijnen van behandeling werd een overall response rate gezien van 60%, 42,5% van de patiënten bereikte een complete remissie; deze responsen waren meestal bestendig (mediane responsduur not reached). Dit is een vergelijkbaar percentage als bijvoorbeeld bij CD19 CART cel behandelingen, wat momenteel als de hoogste standaard wordt gezien bij R/R DLBCL.
Duration of treatment Median 9.3 month / months
Frequency of administration 1 times every 2 weeks
Dosage per administration 12mg/kg
References NCT04150328 https://ashpublications.org/blood/article/134/Supplement_1/1582/427228/Subgroup-Analyses-from-L-Mind-a-Phase-II-Study-of?searchresult=1.
Additional comments The frequency is as follows: • Cycle 1: Administer the infusion on day 1, 4, 8, 15 and 22 of the cycle. • Cycles 2 and 3: Administer the infusion on day 1, 8, 15 and 22 of each cycle. • Cycle 4 until disease progression: Administer the infusion on day 1 and 15 of each cycle. Each cycle has 28 days.

Expected patient volume per year

Patient volume

< 250

Market share is generally not included unless otherwise stated.

References Inschatting Horizonscan Geneesmiddelen axicabtagene ciloleucel.
Additional comments De incidentie van DLBCL (en varianten) in Nederland in 2015 was 1.214 patiënten. Ongeveer 40% van de patiënten reageert niet op de eerste lijnsbehandeling. Ongeveer 50% van de patiënten wordt in de tweedelijn behandeld met autologe stamceltransplantatie. Dit betekent dat naar schatting maximaal 250 van de patiënten in aanmerking zou komen voor behandeling met tafasitamab. Echter worden er beperkte patiëntaantallen verwacht gezien concurrerende geneesmiddelen (CAR-T).

Expected cost per patient per year

References https://pharmaphorum.com/news/incyte-morphosys-take-on-car-ts-as-lymphoma-antibody-monjuvi-approved-in-us/
Additional comments Amerikaanse prijs: "Before any rebates or discounts Monjuvi’s wholesale price will average $16,500 per month in the first year of therapy, followed by an average of $13,000 per month in subsequent years because of a decrease in the required number of doses per cycle. At around $198,000 for the first year". Dit zou neerkomen op zo'n 163.000 euro voor het eerste jaar. De prijs in Nederland voor dit product is nog onbekend.

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 Er lopen op dit moment meerdere fase 2 studies.
References Clinicaltrials.gov.

Other information

There is currently no futher information available.