Drug updated on 9/4/2024
Dosage Form | Film-coated tablet (oral; 20 mg, 40 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with two or more tyrosine kinase inhibitors (TKIs).
- Indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with the T315I mutation.
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Summary
- Scemblix (asciminib) is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with two or more tyrosine kinase inhibitors (TKIs), and for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with the T315I mutation.
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Major Molecular Response (MMR) Rate at 6 Months: Asciminib (Scemblix) shows an MMR rate of 23.3-25.5%, which is higher than omacetaxine (19.2%) and bosutinib (13.2%) but within the range of Ponatinib (19.0-66.7%).
- Complete Cytogenetic Response (CCyR) Rate at 6 Months: Asciminib (Scemblix) demonstrates a CCyR rate of 38.7-40.8%, higher than omacetaxine (16.1%) and bosutinib (18-24.2%) and within Ponatinib's variable range of 21.4-64.8%.
- Population Focus: The data pertains to adult patients with chronic phase-chronic myeloid leukemia (CP-CML) who had received ≥2 prior tyrosine kinase inhibitors (TKIs).
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Scemblix (asciminib) Prescribing Information. | 2023 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Therapy for patients with chronic phase-chronic myeloid leukemia previously treated with ⩾2 tyrosine kinase inhibitors: a systematic literature review. | 2023 | Therapeutic Advances in Hematology |