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Decitabine/cedazuridine

ASTX727

Extended indication

In Europe, INAQOVI (decitabine and cedazuridine) is being developed for the following indication: t

Therapeutic value

Possible benefit in ease of use
Registration phase

Registration application pending

Product

Active substance

Decitabine/cedazuridine
Domain

Hematology
Reason of inclusion

New medicine (specialité)
Main indication

AML / MDS
Extended indication

In Europe, INAQOVI (decitabine and cedazuridine) is being developed for the following indication: treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.
Proprietary name

ASTX727
Manufacturer

Otsuka
Portfolio holder

Otsuka
Route of administration

Oral
Budgetting framework

Intermural (MSZ)
Additional remarks 
First oral formulation of a Hypomethylating  Agent  (HMA)

Registration

Registration route

Centralised (EMA)
Particularity

New therapeutical formulation
ATMP

No
Submission date

2022
Expected Registration

2023
Orphan drug

Yes
Registration phase

Registration application pending
Additional remarks 
Received EMA Orphan Drug Designation in December 2021
EMA filing planned for Q2 2022

Therapeutic value

Current treatment options

Waakzaam wachten; Behandelingen met Epo, transfusies, groeifactoren en/of antibiotica; Behandeling met hypomethylerende geneesmiddelen: azacitidine en decitabine; Milde chemotherapie; Intensieve chemotherapie, al dan niet gevolgd door een allogene stamceltransplantatie ; Doelgerichte therapie.
Therapeutic value

Possible benefit in ease of use
Substantiation

Naar verwachting zal met name concurrentie met azacitidine plaatsvinden. De positie in de richtlijn is nog niet bekend. Echter, is dit nieuwe product oraal en zal er dus wel een mogelijk voordeel in toedieningsgemak zijn.
Frequency of administration

1 times a day
Dosage per administration

oral decitabine (35mg) and cedazuridine (100mg) fixed-dose combination tablet
References 
NCT02103478
NCT03306264
Additional remarks 
NCT03306264: Multicenter, randomized, open-label, crossover PK study of ASTX727 versus IV decitabine. Adult subjects who are candidates to receive IV decitabine will be randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, subjects will continue to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the subject discontinues treatment or withdraws from the study.

Expected patient volume per year

Patient volume

< 700

Market share is generally not included unless otherwise stated.
References 
hematon (1); Ned Tijdschr Geneeskd. 1995;139:2130-5 (2)
Additional remarks 
MDS is een zeldzame ziekte die vooral bij mensen tussen de zestig en negentig jaar voorkomt. Het wordt vaker bij mannen geconstateerd. In Nederland gaat het om ongeveer zevenhonderd nieuwe gevallen per jaar; 
1/ De geschatte incidentie varieert van 5 tot 25 nieuwe patiënten in een populatie van 100.000 personen per jaar.
2/ Het is de verwachting dat de gehele populatie in aanmerking komt voor dit geneesmiddel.

Expected cost per patient per year

References 
drugs.com
Additional remarks 
The cost for Inqovi oral tablet (100 mg-35 mg) is around $7,834 for a supply of 5 tablets, depending on the pharmacy you visit in the US.

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.