Asciminib

Generic Name: Asciminib

Brand Names: Scemblix

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₁₈ClF_₂N_₅O_₃

CAS Number: 1492952-76-7

Unique Ingredient Identifier: L1F3R18W77

Background: Asciminib is a tyrosine kinase inhibitor (TKI) used in the treatment of chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). More specifically, it is an inhibitor of the ABL1 kinase activity of the BCR-ABL1 fusion protein which serves as a driver of CML proliferation in most patients with the disease. It has also shown benefit i...

Indication: Asciminib is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase who have been previously treated with ≥2 tyrosine kinase inhibitors. It is also indicated in the treatment of Ph+ CML in adult patients with the T315I mutation.

Associated Conditions: Chronic Phase Chronic Myeloid Leukemia

Associated Therapies: -

Clinical Trials

ASC4FIRST Trial Supports Asciminib With Secondary End Points in CML

Asciminib (Scemblix) demonstrated superior efficacy and safety compared to investigator-selected tyrosine kinase inhibitors (IS-TKIs) in chronic myeloid leukemia (CML), with a 96-week major molecular response (MMR) rate of 74.1% vs 52.0% for IS-TKIs, meeting key secondary end points of the phase 3 ASC4FIRST trial. The FDA accelerated approval of asciminib was based on 48-week MMR data showing a 68% rate with asciminib vs 49% with IS-TKIs. Asciminib's safety profile continued to outperform imatinib and second-generation TKIs, with a 54% lower risk of treatment discontinuation due to adverse effects.

Related Clinical Trials:

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Drug Development Updates

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