TG Therapeutics Voluntary Withdraws BLA/sNDA for Combination Therapy for Patients with CLL and SLL

TG Therapeutics said it has voluntarily withdrawn the pending Biologics License Application/supplemental New Drug Application for the combination therapy U2 (ublituximab and Ukoniq) for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma because of disappointing new data from a phase 3 trial relating to overall survival.

Photo: Michael Weiss, chairman and CEO of TG Therapeutics

In addition, the company said that it has voluntarily withdrawn Ukoniq from sale for the approved indications of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with follicular lymphoma (FL) who have received at least three prior systemic therapies.

Ukoniq is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. PI3K-delta is known to play an important role in supporting cell proliferation and survival, cell differentiation, intercellular trafficking and immunity and is expressed in both normal and malignant B-cells. CK1-epsilon is a regulator of oncoprotein translation and has been implicated in the pathogenesis of cancer cells, including lymphoid malignancies.

Ukoniq was granted accelerated approval in these indications in February 2021. The company said its decision to withdraw Ukoniq from sale was primarily based on the withdrawal of the BLA and sNDA for U2 in CLL.

“We were very disappointed to see that the recently updated overall survival data showed an increasing survival imbalance in favor of the control arm,” said Michael Weiss, chairman and CEO of TG Therapeutics. “Accordingly, we and our advisors determined that we should withdraw the BLA/sNDA for U2 in CLL. Additionally, we made the difficult decision to withdraw Ukoniq from sale for the approved indications in MZL/FL.”

He said the company will now focus its attention on building out its multiple sclerosis and autoimmune platform.

Author: Rare Daily Staff