Idecabtagene vicleucel

Extended indication	Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD-38 antibody and have demonstrated disease progression on the last therapy.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Idecabtagene vicleucel
Domain	Hematology
Reason of inclusion	Indication extension
Main indication	Multiple Myeloma
Extended indication	Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD-38 antibody and have demonstrated disease progression on the last therapy.
Proprietary name	Abecma
Manufacturer	BMS
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	Yes
Submission date	March 2023
Expected Registration	January 2024
Orphan drug	Yes
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet

There is currently nothing known about the expected patient volume.

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.