Extended indication Relapsed and Refractory Synovial Sarcoma Expressing New York Esophageal Antigen-1 (NY-ESO-1) and/or
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance NY-ESO-1 autologous engineered TCR-T cells
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Other oncology
Extended indication Relapsed and Refractory Synovial Sarcoma Expressing New York Esophageal Antigen-1 (NY-ESO-1) and/or LAGE-1a.
Manufacturer GSK
Mechanism of action Autologous modified cell therapy
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments NY-ESO-1 autologous engineered TCR-T cells (engineered TCR).

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

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 NCT03697824
Additional comments De fase 2 studie NCT03697824 is teruggetrokken en wordt vervangen door een studie naar monotherapie.

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 comments In 2016 waren er 34 wekedelensarcomen 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 comments 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.