Asciminib

Active substance
Asciminib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Leukemia
Extended indication
Philadelphia chromosoom positieve (Ph+) Chronische Myeloïde Leukemie (CML) in 3e lijn.

1. Product

Manufacturer
Novartis
Mechanism of action
Tyrosine kinase inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
March 2021
Expected Registration
June 2022
Orphan drug
No
Registration phase
Clinical trials

3. Therapeutic value

Current treatment options
Verschillende TKI's: imatinib, nilotinib, dasatinib, bosutinib, ponatinib
Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
2 times a day
Dosage per administration
40 mg
References
N Engl J Med. 2019 Dec 12;381(24):2315-2326. doi: 10.1056/NEJMoa1902328. NCT03106779

4. Expected patient volume per year

References
NCCN clinical pratice guidelines CML 2018; NKR; fabrikant
Additional comments
Volgens de NCCN clinical practice guidelines voor CML, wordt in 2021 naar verwachting circa 15% van de CML patiënten in de 3e lijn behandeld. Volgens het NKR zijn er in 2017 210 diagnoses van Chronische Myeloïde Leukemie gesteld. Dit betekent dat er 32 patiënten in aanmerking zullen komen voor deze behandeling.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
1e lijn Ph+ CML
References
fabrikant
Additional comments
In 2025

9. Other information

There is currently no futher information available.