Expand all sections

Asciminib

Extended indication Philadelphia chromosoom positieve (Ph+) Chronische Myeloïde Leukemie (CML) in 3e lijn.
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Asciminib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Leukemia
Extended indication Philadelphia chromosoom positieve (Ph+) Chronische Myeloïde Leukemie (CML) in 3e lijn.
Manufacturer Novartis
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

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

Therapeutic value

Current treatment options Verschillende TKI's: imatinib, nilotinib, dasatinib, bosutinib, ponatinib.
Therapeutic value No judgement
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.

Expected patient volume per year

References NCCN clinical pratice guidelines CML 2018; NKR; fabrikant.
Additional remarks 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.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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

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

Other information

There is currently no futher information available.