Decitabine / cedazuridine

Extended indication	Extension of indication to include treatment of adult patients with myelodysplastic syndromes (MDS) and treatment of adult patients with chronic myelomonocytic leukaemia (CMML).
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Decitabine / cedazuridine
Domain	Oncology
Reason of inclusion	Indication extension
Extended indication	Extension of indication to include treatment of adult patients with myelodysplastic syndromes (MDS) and treatment of adult patients with chronic myelomonocytic leukaemia (CMML).
Proprietary name	Inaqovi
Manufacturer	Otsuka
Route of administration	Oral
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	January 2024
Expected Registration	November 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.