Difference between revisions of "Asciminib (Scemblix)"

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

Chronic myeloid leukemia

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

@@ Line 1: / Line 1: @@
 ==Mechanism of action==
-From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/allosteric-bcr-abl-tyrosine-kinase-inhibitor-abl001 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. This binding results in the inhibition of Bcr-Abl-mediated proliferation and enhanced apoptosis of Philadelphia chromosome-positive (Ph+) hematological malignancies.
+From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/allosteric-bcr-abl-tyrosine-kinase-inhibitor-abl001 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.
-==Preliminary data==
+==Diseases for which it is used==
-===[[Chronic myelogenous leukemia]]===
+*[[Chronic myeloid leukemia]]
-# '''CABL001X2101:''' Hughes TP, Mauro MJ, Cortes JE, Minami H, Rea D, DeAngelo DJ, Breccia M, Goh YT, Talpaz M, Hochhaus A, le Coutre P, Ottmann O, Heinrich MC, Steegmann JL, Deininger MWN, Janssen JJWM, Mahon FX, Minami Y, Yeung D, Ross DM, Tallman MS, Park JH, Druker BJ, Hynds D, Duan Y, Meille C, Hourcade-Potelleret F, Vanasse KG, Lang F, Kim DW. Asciminib in Chronic Myeloid Leukemia after ABL Kinase Inhibitor Failure. N Engl J Med. 2019 Dec 12;381(24):2315-2326. [https://www.nejm.org/doi/full/10.1056/NEJMoa1902328 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31826340 PubMed]
+==History of changes in FDA indication==
+*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)''
+**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==
+*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==
+*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==
+*'''Code name:''' ABL-001
+*'''Brand name:''' Scemblix
 [[Category:Drugs]]
 [[Category:Oral medications]]
-[[Category:Kinase inhibitors]]
+[[Category:STAMP inhibitors]]
-[[Category:Bcr-Abl inhibitors]]
+[[Category:Chronic myeloid leukemia medications]]
+[[Category:FDA approved in 2021]]
-[[Category:Investigational drugs]]
+[[Category:EMA approved in 2022]]
+[[Category:Health Canada approved in 2022]]
+[[Category:PMDA approved in 2022]]