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Asciminib

Brand: Scemblix

Kinase Inhibitor, BCR-ABL Inhibitor

AntineoplasticTargeted Therapy

ApprovedPrescription Only

Overview

Asciminib, sold under the brand name Scemblix, is a kinase inhibitor used to treat certain types of chronic myeloid leukemia (CML). Specifically, it is indicated for adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs). It works by targeting the ABL myristoyl pocket (STAMP), a unique binding site on the BCR-ABL1 protein, which drives the growth of CML cells. This mechanism of action differentiates it from other TKIs and allows it to overcome resistance mechanisms that can develop with these therapies.

Primary Use

Asciminib is used to treat adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors.

Pharmacokinetics

Within a few hours

Onset

Approximately 27 hours

Half-Life

200 mg

Max Dose

Liver (CYP3A4)

Metabolism

Clinical Applications

Approved Indications

Chronic myeloid leukemia (CML) in chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs)

Off-Label Uses

Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to standard therapies

Systemic mastocytosis (SM) with D816V mutation unresponsive to other TKIs

Side Effects

Arthralgia

Headache

Fatigue

Nausea

Diarrhea

Drug Interactions

Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole)

High

Outcome:

Increased asciminib exposure

Mechanism:

Reduced metabolism of asciminib

Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole)

Moderate

Outcome:

Increased asciminib exposure

Mechanism:

Reduced metabolism of asciminib

Food (high-fat meals)

Low

Outcome:

Increased asciminib absorption

Mechanism:

Enhanced solubility in the presence of fats

AI Predictions & Insights

Innovation Forecast

Most likely new formulation: combination therapy with other targeted agents (Year: 2025, 70% confidence)

Regulatory Outlook

Based on clinical trial data and increasing adoption, asciminib has a high likelihood of remaining a key treatment option for TKI-resistant CML.

Classification & Chemical Information

Primary Classification

Kinase Inhibitor, BCR-ABL Inhibitor

Chemical Class

Pyrimidinone derivative

Asciminib (Scemblix): Uses, Dosage, Side Effects & Interactions