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 1^st 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