Umbralisib (Ukoniq)

Mechanism of action

Phosphatidylinositol 3-kinase (PI3K) isoform p110δ (PI3Kδ) and casein kinase-1ε inhibitor

Diseases for which it was used

• Follicular lymphoma
• Marginal zone lymphoma

Patient Drug Information

• Umbralisib (Ukoniq) Package Insert

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  • 2022-06-01: Accelerated approval withdrawn due to safety concerns.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  • 2022-06-01: Accelerated approval withdrawn due to safety concerns.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