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
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments 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
Submission date January 2022
Expected Registration November 2022
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
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 comments In het pakketadvies voor daratumumab wordt het aantal patiënten in de tweede lijn ingeschat op 651.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.