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TG Therapeutics Voluntary Withdrawal BLA/sNDA of U2 for Patients with CLL and SLL

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TG Therapeutics Voluntary Withdrawal BLA/sNDA of U2 for Patients with CLL and SLL

TG Therapeutics Voluntary Withdrawal BLA/sNDA of U2 for Patients with CLL and SLL

Shots:

  • The withdrawal was based on data of the P-III UNITY-CLL study that demonstrated ab increasing imbalance in OS. The trial compared U2 to an active control arm of obinutuzumab + chlorambucil in patients with both treatment-naïve & R/R CLL
  • Additionally, the company has also withdrawn Ukoniq from sale for the approved indications of adult patients with MZL who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with FL prior treated with at least three systemic therapies
  • Ukoniq is the first and only oral inhibitor of PI3K delta and CK1 epsilon and is currently under FDA’s review for relapsing forms of MS with an anticipated PDUFA date of Sep 28, 2022

Ref: TG Therapeutics | Image: TG Therapeutics

Click here to­ read the full press release 

Neha

Neha Madan is a content writer at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots.

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