TG Therapeutics’ Ukoniq (umbralisib) Receives the US FDA’s Approval for R/R Marginal Zone Lymphoma and Follicular Lymphoma

 TG Therapeutics’ Ukoniq (umbralisib) Receives the US FDA’s Approval for R/R Marginal Zone Lymphoma and Follicular Lymphoma

TG Therapeutics’ Ukoniq (umbralisib) Receives the US FDA’s Approval for R/R Marginal Zone Lymphoma and Follicular Lymphoma

Shots:

  • The approvals is based on P-II UNITY-NHL trial involves assessing Ukoniq (800 mg, qd) in 69 patients with MZL who has received at least 1 prior anti-CD20 based regimen and in 117 patients with FL who received at least 2 prior systemic therapies
  • Results: ORR (49% vs 50%) as assessed by IRC, CR (16% vs 3.4%), PR (33% vs 39%), DoR of FL was 11.1 mos.
  • Ukoniq is the 1st oral inhibitor of PI3K delta and CK1 epsilon. Additionally, it has received BTD for MZL and ODD for MZL and FL

Click here ­to­ read full press release/ article | Ref: TG Therapeutics | Image: Seeking Alpha

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