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 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.

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.