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TG Therapeutics (NASDAQ:TGTX) said it is voluntarily withdrawing Ukoniq from sale for the approved indications of relapsed/refractory marginal zone lymphoma (MZL) and (FL).
The company has also withdrawn its biologics license application (BLA)/supplemental new drug application (sNDA) for the combination of ublituximab and Ukoniq (umbralisib) to treat adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) after overall survival data from a phase 3 trial, dubbed UNITY-CLL, showed an increasing survival imbalance in favor of the control arm.
The New York-based company said the decision to withdraw Ukoniq from sale was mainly based on the withdrawal of the BLA and sNDA for the drug combo referred as 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 TG Chairman and CEO Michael Weiss.
"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," added Weiss.
Ukoniq was granted accelerated approval in February 2021 to treat adult patients with MZL who have received at least one prior anti-CD20-based regimen and to treat adult patients with FL who have received at least three prior systemic therapies.
The company said it expects the FDA will withdraw the accelerated approval of Ukoniq as it was withdrawing the drug from sale.
In March, the FDA had extended the review of the BLA/sNDA as the FDA needed more time to study the updated overall survival analyses submitted by the company.
In January, Weiss, had notified that the FDA had put partial clinical hold on U2 combination studies in CLL and non-Hodgkin's lymphoma (NHL).
TGTX -24.29% to $6.70 premarket April 13