Difference between revisions of "Umbralisib (Ukoniq)"
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(Created page with "==Mechanism of action== Phosphatidylinositol 3-kinase (PI3K) isoform p110δ (PI3Kδ) and casein kinase-1ε inhibitor ==Also known as== *'''Code name:''' TGR-1202 Category:...") |
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==Mechanism of action== | ==Mechanism of action== | ||
Phosphatidylinositol 3-kinase (PI3K) isoform p110δ (PI3Kδ) and casein kinase-1ε inhibitor | Phosphatidylinositol 3-kinase (PI3K) isoform p110δ (PI3Kδ) and casein kinase-1ε inhibitor | ||
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| + | ==Diseases for which it was used== | ||
| + | *[[Follicular lymphoma - historical|Follicular lymphoma]] | ||
| + | *[[Marginal zone lymphoma - historical|Marginal zone lymphoma]] | ||
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| + | == Patient Drug Information== | ||
| + | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213176s000lbl.pdf Umbralisib (Ukoniq) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213176s000lbl.pdf Umbralisib (Ukoniq) Package Insert]</ref> | ||
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| + | ==History of changes in FDA indication== | ||
| + | *2021-02-05: Accelerated approval for adult patients with relapsed or refractory [[marginal zone lymphoma|marginal zone lymphoma (MZL)]] who have received at least one prior [[Regimen_classes#Anti-CD20-based_regimen|anti-CD20-based regimen]]. ''(Based on UNITY-NHL)'' | ||
| + | **2022-06-01: Accelerated approval withdrawn due to safety concerns. ''(Based on UNITY-CLL)'' | ||
| + | *2021-02-05: Accelerated approval for adult patients with relapsed or refractory [[Follicular lymphoma|follicular lymphoma (FL)]] who have received at least three prior lines of systemic therapy. ''(Based on UNITY-NHL)'' | ||
| + | **2022-06-01: Accelerated approval withdrawn due to safety concerns. ''(Based on UNITY-CLL)'' | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' TGR-1202 | *'''Code name:''' TGR-1202 | ||
| + | *'''Brand name:''' Ukoniq | ||
| + | ==References== | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
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[[Category:PI3K delta inhibitors]] | [[Category:PI3K delta inhibitors]] | ||
[[Category:CK1 epsilon inhibitors]] | [[Category:CK1 epsilon inhibitors]] | ||
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| − | [[Category: | + | [[Category:Follicular lymphoma medications (historic)]] |
| + | [[Category:Marginal zone lymphoma medications (historic)]] | ||
| + | [[Category:FDA approved in 2021]] | ||
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| + | [[Category:Discontinued drugs]] | ||
| + | [[Category:FDA withdrawn in 2022]] | ||
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| + | [[Category:TG Therapeutics compound]] | ||
Latest revision as of 11:41, 9 April 2024
Mechanism of action
Phosphatidylinositol 3-kinase (PI3K) isoform p110δ (PI3Kδ) and casein kinase-1ε inhibitor
Diseases for which it was used
Patient Drug Information
History of changes in FDA indication
- 2021-02-05: Accelerated approval for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen. (Based on UNITY-NHL)
- 2022-06-01: Accelerated approval withdrawn due to safety concerns. (Based on UNITY-CLL)
- 2021-02-05: Accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. (Based on UNITY-NHL)
- 2022-06-01: Accelerated approval withdrawn due to safety concerns. (Based on UNITY-CLL)
Also known as
- Code name: TGR-1202
- Brand name: Ukoniq