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Tabelecleucel

Extended indication Treatment of patients with Epstein-Barr Virus-associated Post Transplant Lymphoproliferative Disorde
Therapeutic value No judgement
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 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)
Submission date 2020
Expected Registration 2021
Orphan drug Yes
Registration phase Clinical trials
Additional remarks ATMP, PRIME

Therapeutic value

Current treatment options EMA: "At the time of designation, no satisfactory method were authorised in the European Union for the treatment of post-transplant lymphoproliferative disorder. Patients with the condition were treated with medicines authorised for non-Hodgkin’s lymphoma."
Therapeutic value No judgement
Frequency of administration 3 times every 5 weeks
References klinische studies: ALLELE en MATCH
Additional remarks Tabelecleucel will be administered in cycles lasting 5 weeks (35 days). During each cycle, subjects will receive IV tabelecleucel at a dose of 2×10^6 cells/kg on Days 1, 8, and 15, followed by observation through Day 35. Participants may receive more than one cycle of therapy as required.

Expected patient volume per year

References Vektis
Additional remarks Op basis van de add-on declaratiegegevens voor rituximab bij de indicatie: Behandeling van post-transplantatie lymfoproliferatieve ziekte (PTLD) na orgaan- of stamcel transplantatie bij volwassenen kan worden geconcludeerd dat er in 2017 ongeveer 30 patiënten dit middel hebben gekregen en in 2018 44 patiënten. De declaratiegegevens van 2018 zijn echter nog incompleet. Om die reden 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.