Extended indication Treatment of patients with Epstein-Barr Virus-associated Post Transplant Lymphoproliferative Disorde
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Tabelecleucel
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Stem cell transplants
Extended indication Treatment of patients with Epstein-Barr Virus-associated Post Transplant Lymphoproliferative Disorder in the allogeneic hematopoietic cell transplant setting who have failed on rituximab.
Manufacturer Atara
Mechanism of action Allogeneic modified cell therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments 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 2022
Expected Registration 2023
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 3 times every 5 weeks
References klinische studies: ALLELE en MATCH.
Additional comments 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 dagen 1, 8 en 15. Indien nodig worden meerdere behandelcycli gevolgd.

Expected patient volume per year

Additional comments Op basis van de declaratiegegevens voor rituximab bij de indicatie: Behandeling van post-transplantatie lymfoproliferatieve ziekte (PTLD) na orgaan- of stamcel transplantatie bij volwassenen, is de inschatting dat er zo'n 30-50 patiënten rituxmab krijgen bij PTLD. Gezien rituximab echter relatief goed werkt voor deze groep patiënten is de verwachting dat slechts een deel hiervan in aanmerking zal komen voor tabelecleucel.

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.