Version 1

Teclistimab

Medicine

Extended indication Patients with relapsed or refractory multiple myeloma
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Teclistimab
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication Multiple Myeloma
Extended indication Patients with relapsed or refractory multiple myeloma
Manufacturer Janssen
Mechanism of action Unknown
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Bispecifiek antilichaam dat bindt aan BCMA en CD3 zodat T-cellen worden geleid naar multipel myeloom cellen.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Particularity Unknown
ATMP Unknown
Submission date January 2022
Expected Registration November 2022
Orphan drug Unknown
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Frequency of administration 1 times a week
Dosage per administration 1500 µg/kg
References MajesTEC-1; NCT03145181; NCT04557098; Usmani, S. Z., Garfall, A. L., van de Donk, N. W. C. J., Nahi, H., San-Miguel, J. F., Oriol, A., … Krishnan, A. (2021). Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. The Lancet, 398(10301), 665–674.

Expected patient volume per year

Patient volume < 651

Market share is generally not included unless otherwise stated.
References Pakketadvies daratumumab (Darzalex®) bij multipel myeloom (ziekte van Kahler), ZIN 2017, expert opinie.
Additional remarks In het pakketadvies voor daratumumab wordt het aantal patiënten in de tweede lijn ingeschat op 651.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information