Teclistimab

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 remarks	Bispecifiek antilichaam dat bindt aan BCMA en CD3 zodat T-cellen worden geleid naar multipel myeloom cellen.

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

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.

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.

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.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.