TG Therapeutics pulls BLA/sNDA for U2 in CLL and SLL and sale of Ukoniq

TG Therapeutics pulls BLA/sNDA for U2 in CLL and SLL and sale of Ukoniq

US biotech TG Therapeutics (Nasdaq: TGTX) saw its shares plunge almost 32% to $6.03, after it announced the voluntary withdrawal of the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and Ukoniq (umbralisib) - combination referred to as U2 - for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The decision to withdraw was based on recently updated overall survival (OS) data from the UNITY-CLL Phase III trial that showed an increasing imbalance in OS.

In addition, the company announced that it has voluntarily withdrawn Ukoniq from sale for the approved indications of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen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 was granted accelerated approval in these indications by the Food and Drug Administration in February 2021. The company’s decision to withdraw Ukoniq from the market was primarily based on the withdrawal of the BLA and sNDA for U2 in CLL.

Michael Weiss, chairman and chief executive of TG Therapeutics stated: “We were very disappointed to see that the recently updated overall survival data showed an increasing survival imbalance in favor of the control arm. 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.”

Will focus on multiple sclerosis and autoimmune platform
Mr Weiss continued: “While we had hoped to bring U2 to patients with CLL, this will now permit us to focus our attention, passion and energy to building out our multiple sclerosis and autoimmune platform. With our ublituximab BLA pending for patients with relapsing forms of multiple sclerosis and a PDUFA goal date of September 28, 2022, we are excited about the possibility of bringing ublituximab to patients with RMS. If approved, we believe the differentiated profile of ublituximab with its one-hour infusion will be welcomed by the MS community.”

Pursuant to a recent information request made by the FDA, updated OS data were collected that showed an increasing imbalance in favor of the control arm, differing from the improved results provided to the FDA in February 2022. Based on these new data, the company decided to withdraw the pending BLA/sNDA for U2 to treat CLL/SLL and accordingly the April 22, 2022, ODAC meeting will be cancelled.

In addition, based on the company’s decision to withdraw Ukoniq from sale, it anticipates that the FDA will withdraw the accelerated approval for the product.

The FDA also has scheduled an ODAC meeting for April 21, 2022, in which it plans to discuss the appropriate approach for phosphatidylinositol-3-kinase inhibitors under development for treatment of hematologic malignancies. Ukoniq is within this class of drugs and may be discussed during this meeting.

19-04-2022

https://www.thepharmaletter.com/

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