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Letetresgene autoleucel

Extended indication Letetresgene autoleucel in combination with fludarabine and cyclophosphamide for second line or late
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Letetresgene autoleucel
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Letetresgene autoleucel in combination with fludarabine and cyclophosphamide for second line or later treatment of advanced (metastatic or unresectable) HLA-A2-positive, NY-ESO1-positive and/or LAGE-1a-positive myxoid/round cell liposarcoma or Synovial sarcoma in children over 10 years of age, adolescents, adults and elderly who have disease progression following treatment with anthracycline based chemotherapy
Manufacturer Adaptimmune
Mechanism of action Autologous modified cell therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks NY-ESO-1 autologous engineered TCR-T cells (engineered TCR). Fabrikant: adaptimmuno

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Particularity New medicine with Priority Medicines (PRIME)
ATMP Yes
Submission date February 2025
Expected Registration November 2025
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options Bestraling en chemotherapie.
Therapeutic value No estimate possible yet
Duration of treatment one-off
Dosage per administration 1 tot 6 x10^9 cellen
References NCT03967223 (IGNYTE-ESO)

Expected patient volume per year

Patient volume

5

Market share is generally not included unless otherwise stated.
References NKR; https://mens-en-gezondheid.infonu.nl/aandoeningen/187822-synoviaal-sarcoom-kanker-van-weefsel-rond-gewrichten.html#behandeling; Lai et al. Oncoimmunology. 2012 Nov 1; 1(8): 1409–1410.
Additional remarks In 2016 waren er 34 wekedelen sarcomen van de extremiteiten gediagnosticeerd, waar het synoviaal carcinoom er een van is. De incidentie van dit synoviaal carcinoom wordt geschat op 1 in de 3 miljoen, ongeveer 6 per jaar in Nederland. Expressie van NY-ESO-1 komt voor in ongeveer 80% van de gevallen van synoviaal sarcoom (5 patiënten).

Expected cost per patient per year

Additional remarks Gezien de PRIME-status zal deze behandeling waarschijnlijk hoge kosten met zich meebrengen.

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 Gastrointestinal cancer, Malignant melanoma, Multiple myeloma, Non-small cell lung cancer, Ovarian cancer, Liposarcoma.
References AdisInsight

Other information

There is currently no futher information available.