Extended indication Philadelphia chromosoom positieve (Ph+) Chronische Myeloïde Leukemie (CML) in derde lijn.
Therapeutic value No estimate possible yet
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 derde 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 July 2021
Expected Registration August 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Verschillende TKI's: imatinib, nilotinib, dasatinib, bosutinib, ponatinib.
Therapeutic value No estimate possible yet
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 comments Volgens de NCCN clinical practice guidelines voor CML, wordt in 2021 naar verwachting circa 15% van de CML patiënten in de derde lijn behandeld. In 2017 zijn er volgens het NKR 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 comments In 2025.

Other information

There is currently no futher information available.