Difference between revisions of "Asciminib (Scemblix)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *10 | + | *2021-10-29: Granted accelerated approval for patients with [[Biomarkers#BCR-ABL1|Philadelphia chromosome-positive]] [[Chronic myeloid leukemia|chronic myeloid leukemia]] (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). ''(Based on ASCEMBL)'' |
| − | *10 | + | **2022-10-12: Converted to regular approval. |
| + | *2021-10-29: Approved for adult patients with [[Biomarkers#BCR-ABL1|Ph+]] [[Chronic myeloid leukemia|CML]] in CP with the [[Biomarkers#T315I|T315I]] mutation. ''(Based on CABL001X2101)'' | ||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2022-08-25: Initial authorization |
==Also known as== | ==Also known as== | ||
*'''Code name:''' ABL001 | *'''Code name:''' ABL001 | ||
Revision as of 12:04, 21 April 2023
Mechanism of action
From the NCI Drug Dictionary: An orally bioavailable, allosteric Bcr-Abl tyrosine kinase inhibitor with potential antineoplastic activity. Designed to overcome resistance, asciminib binds to the Abl portion of the Bcr-Abl fusion protein at a location that is distinct from the ATP-binding domain, and is a so-called STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor. This binding results in the inhibition of Bcr-Abl-mediated proliferation and enhanced apoptosis of Philadelphia chromosome-positive (Ph+) hematological malignancies.
Diseases for which it is used
History of changes in FDA indication
- 2021-10-29: Granted accelerated approval for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). (Based on ASCEMBL)
- 2022-10-12: Converted to regular approval.
- 2021-10-29: Approved for adult patients with Ph+ CML in CP with the T315I mutation. (Based on CABL001X2101)
History of changes in EMA indication
- 2022-08-25: Initial authorization
Also known as
- Code name: ABL001
- Brand name: Scemblix