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Tabelecleucel

Ebvallo

Extended indication Ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age an
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Tabelecleucel
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication Stem cell transplants
Extended indication Ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.
Proprietary name Ebvallo
Manufacturer Atara
Portfolio holder Pierre Fabre
Mechanism of action Allogeneic modified cell therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Particularity New medicine with Priority Medicines (PRIME)
ATMP Yes
Submission date October 2021
Expected Registration December 2022
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP opinie ontvangen oktober 2022.

Therapeutic value

Current treatment options Rituximab
Therapeutic value No estimate possible yet
Substantiation De huidige behandeling is redelijk effectief. Er zijn nog geen resultaten uit de studie bekend. Mogelijk is er weinig vraag naar een nieuwe behandeloptie.
Duration of treatment Average 3 month / months
Frequency of administration 3 times every 5 weeks
References NCT03394365 (ALLELE)
Additional remarks Tabelecleucel wordt toegediend in cycli van 5 weken (35 dagen). Gedurende elke cyclus zal tabelecleucel worden toegediend in een dosis van 2×10^6 cellen/kg op dag 1, 8 en 15. Indien nodig worden meerdere behandelcycli gevolgd. De cut-off data in de ALLELE studie kwam uit op gemiddeld 7,56 doseringen.

Expected patient volume per year

Patient volume

23 - 35

Market share is generally not included unless otherwise stated.
References (1) Declaratiegegevens; 2) Garcia-Cadenas et al. 2019; Eur J Haematol; 3) Jagadeesh et al. 2020 J Clin Oncol; 4) Trappe et al. 2017, J Clin Oncol
Additional remarks Op basis van declaratiegegevens uit 2020 voor rituximab bij de indicatie: Behandeling van post-transplantatie lymfoproliferatieve ziekte (PTLD) na orgaan- of stamcel transplantatie bij volwassenen, is de inschatting dat er maximaal 71 mensen rituximab krijgen tegen PTLD (1). Het is niet bekend welk type transplantatie deze patiënten heeft gehad. Dat is relevant aangezien patiënten met stamceltransplantaties (HCT) vaker rituximab refractair zijn (50%) dan orgaantransplantatie (SOT) patiënten (33%) (2,3,4). Dit bevindt zich dus ergens tussen 23 en 35 patiënten.

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 www.clinicaltrials.gov.

Other information

There is currently no futher information available.