Difference between revisions of "Umbralisib (Ukoniq)"
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==History of changes in FDA indication== | ==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)'' |
| − | * | + | *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| − | * | + | *2022-06-01: Approval withdrawn due to safety concerns. ''(Based on UNITY-CLL)'' |
==Also known as== | ==Also known as== | ||
Revision as of 12:58, 17 April 2023
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)
- 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- 2022-06-01: Approval withdrawn due to safety concerns. (Based on UNITY-CLL)
Also known as
- Code name: TGR-1202
- Brand name: Ukoniq