This "New" Lymphoma Drug Had Only Been on the Market Since February 2021, When Ukoniq Received FDA Accelerated Approval
In February 2022 we wrote about this Drug Safety Communication, "FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)", and we closed that article stating: "We will continue to monitor this Ukoniq safety signal and watch for any related FDA regulatory action, including a possible Ukoniq drug recall in the future." Now, less than three months after the FDA warning about an increased number of deaths in lymphoma patients treated with Ukoniq, the responsible drug company, TG Therapeutics, has recalled Ukoniq from the market.
For background, here are two earlier Drug Injury Watch articles about Ukoniq:
- Ukoniq Lymphoma Drug Safety Investigation Started In February 2022 to Examine Increased Risk of Death (February 4, 2022)
- Ukoniq FDA Advisory Committee Meeting in April 2022 Will Evaluate Ukoniq Drug Safety Findings (March 15, 2022)
Now, we point out some recent news reports about this April 2022 Ukoniq drug recall.
We start with an April 15, 2022 Dow Jones piece, "TG Therapeutics Pulls Sole Product Ukoniq Amid Increased Death Risk", which sets the stage for some more in-depth analysis of events leading up to this Ukoniq recall:
TG Therapeutics Inc. on Friday said it is pulling its Ukoniq lymphoma treatment from the market after a study showed a possible increased risk of death in patients taking the drug.
The New York biopharmaceutical company also said it is withdrawing its application seeking U.S. Food and Drug Administration approval of Ukoniq in combination with ublituximab for the treatment of adults with chronic lymphocytic leukemia and small lymphocytic lymphoma.
TG Therapeutics said it made the decision after recently updated overall-survival data from a Phase 3 study of the combination showed an increasing survival imbalance in favor of the control arm.
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Next, for a more detailed discussion about why the drug company has recalled Ukoniq, there is this April 15, 2022 news report published by BioSpace, "TG Therapeutics Backpedals on BLA for Lymphoma, Leukemia Treatment":
New York-based TG Therapeutics voluntarily withdrew its pending Biologics License Application (BLA) and supplemental New Drug Application (sNDA) for its combination of ublituximab and Ukoniq (umbralisib), dubbed U2, for adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
The company indicates the withdrawal was due to recently updated overall survival (OS) data from the Phase III Unity-CLL trial “that showed an increasing imbalance in OS.” The trial compared U2 to an active control arm of Obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory CLL. That trial hit the primary endpoint, with U2 significantly prolonging assessed progression-free survival (PFS) compared to the control arm.
Based on that study, a BLA and sNDA were submitted to the U.S. Food and Drug Administration for CLL/SLL.
The FDA informed TG Therapeutics in November 2021 that it was going to run an Oncologic Drug Advisory Committee (ODAC) meeting over the review to discuss the benefit-risk profile of Ukoniq in its approved indications. There were several concerns, apparently, but the FDA’s primary issue seemed to be from an early ad hoc analysis of OS in the Unity-CLL study....
The FDA then requested more data. This demonstrated an increasing imbalance favoring the control arm, which didn’t correlate with the data they provided the FDA in February 2022. Based on the new information, TG Therapeutics decided to withdraw the BLA/sNDA for U2 to treat CLL/SLL. The FDA also is canceling the ODAC meeting. TG also expects the FDA to withdraw the accelerated approval for Ukoniq.
Third, from "U2 disbands: In a crushing step back, TG retracts FDA request for combo therapy due to death risk", a Fierce Biotech article with some contextual facts concerning the April 2022 Ukoniq drug recall:
Ukoniq’s fall from grace comes less than 15 months after it first hit the market through the FDA’s accelerated approval pathway to treat two types of blood cancer. According to phase 2 data used to validate the approval, the overall response rate among patients with relapsed refractory marginal zone lymphoma who had previously received at least one line of treatment was 49%. For patients with relapsed or refractory follicular lymphoma after at least three lines of treatment, the overall response rate was 43%. Among 221 patients from three single-arm, open-label studies, serious side effects were reported in 18% of patients. Ukoniq joined a list of other PI3K delta inhibitors to treat cancer, which have been known to have high toxicity risks.
Lastly, here is the April 15, 2022 company Press Release about the Ukoniq recall, "TG Therapeutics Announces Voluntary Withdrawal of the BLA/sNDA for U2 to Treat Patients with CLL and SLL".
In connection with this April 2022 Ukoniq drug recall for safety reasons, we are investigating possible Ukoniq drug injury lawsuits against TG Therapeutics for cases involving patient deaths or serious side effects that may have been caused by Ukoniq.
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