Difference between revisions of "Asciminib (Scemblix)"
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*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)'' | *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 | + | *2022-08-25: Initial authorization as Scemblix. Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive [[chronic myeloid leukemia|chronic myeloid leukaemia]] in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors. ''(Based on ASCEMBL & CABL001X2101)'' |
| + | |||
| + | ==History of changes in Health Canada indication== | ||
| + | *2022-06-22: Initial notice of compliance | ||
==History of changes in PMDA indication== | ==History of changes in PMDA indication== | ||
*2022-03-28: Newly indicated for the treatment of [[Chronic myeloid leukemia|chronic myelogenous leukemia]] with resistance or intolerance to prior drug therapies. | *2022-03-28: Newly indicated for the treatment of [[Chronic myeloid leukemia|chronic myelogenous leukemia]] with resistance or intolerance to prior drug therapies. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' ABL-001 |
*'''Brand name:''' Scemblix | *'''Brand name:''' Scemblix | ||
| Line 24: | Line 27: | ||
[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
[[Category:EMA approved in 2022]] | [[Category:EMA approved in 2022]] | ||
| + | [[Category:Health Canada approved in 2022]] | ||
[[Category:PMDA approved in 2022]] | [[Category:PMDA approved in 2022]] | ||
Latest revision as of 00:50, 9 September 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 as Scemblix. Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors. (Based on ASCEMBL & CABL001X2101)
History of changes in Health Canada indication
- 2022-06-22: Initial notice of compliance
History of changes in PMDA indication
- 2022-03-28: Newly indicated for the treatment of chronic myelogenous leukemia with resistance or intolerance to prior drug therapies.
Also known as
- Code name: ABL-001
- Brand name: Scemblix