Asciminib: First Approval.
Drugs
; 82(2): 219-226, 2022 Feb.
Article
in En
| MEDLINE
| ID: mdl-35041175
ABSTRACT
Asciminib (Scemblix®) is an orally administered, small molecule, selective allosteric inhibitor that targets the myristoyl pocket of the BCR-ABL1 tyrosine kinase and is being developed by Novartis for the treatment of haematological malignancies, including Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML). The drug is active against a number of the single catalytic-site mutations, such as T315I, that confer resistance to conventional tyrosine kinase inhibitors (TKIs) that bind to the ATP-binding site of BCR-ABL1. In October 2021, asciminib monotherapy was granted accelerated approval for the treatment of adults with Ph+ CML in chronic phase (CML-CP), previously treated with ≥ 2 TKIs, and full approval for the treatment of adults with Ph+ CML-CP with the T315I mutation. The drug is under regulatory review for use as monotherapy in CML in the EU, and is in phase 1-3 development exploring its potential in first-line, later-line and paediatric patients with CML. This article summarizes the milestones in the development of asciminib leading to this first approval for the treatment of adults with Ph+ CML-CP, previously treated with ≥ 2 TKIs, and Ph+ CML-CP with the T315I mutation.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pyrazoles
/
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
/
Niacinamide
/
Protein Kinase Inhibitors
/
Antineoplastic Agents
Type of study:
Clinical_trials
Limits:
Humans
Language:
En
Journal:
Drugs
Year:
2022
Document type:
Article
Affiliation country:
Nueva Zelanda