FDA Withdraws Approval of Ukoniq


The FDA indicated the risk of death outweighs the benefits of Ukoniq, which was approved in February 2021 to treat specific lymphomas.

The FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma and follicular lymphoma. The agency is advising healthcare professionals to stop prescribing Ukoniq and switch patients to alternative treatments.

Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq for the treatment of patients with chronic lymphocytic leukemia. As a result, regulators determined the risks of treatment with Ukoniq outweigh its benefits.

In January 2022, TG Therapeutics announced a partial clinical hold on Ukoniq for chronic lymphocytic leukemia and non-Hodgkin lymphoma. Although the trial met its endpoint progression-free survival, a first analysis of overall survival showed a hazard ration of 1.23. An overall survival hazard ratio above 1.00 implies potential risk that the investigational therapy is causing harm. But based on the ad hoc nature of the analysis, about 15% of patients had missing or outdated survival data. And when excluding deaths related to COVID-19, the hazard ration was 1.04.

Related: FDA: Ukoniq Under Investigation for Possible Risk of Death

Based upon this data, TG Therapeutics announced it was voluntarily withdrawing Ukoniq from the market for the approved uses in marginal zone lymphoma and follicular lymphoma.

The company indicated, however, it was still pursuing Ukoniq to treat patients with multiple sclerosis and autoimmune platform. The company’s biologics licensing application with the FDA is pending for patients with relapsing forms of multiple sclerosis. The FDA has extended the PDUFA goal date to Dec. 28, 2022, from the original date of Sept. 28, 2022. The FDA extended the to allow time to review a submission provided by the company in response to an FDA information request, which the FDA indicated was a major amendment.

The submission is based on the ULTIMATE I and ULTIMATE 2 phase 3 trials. Pooled post hoc analyses demonstrated a significant improvement in multiple measures of disability progression with ublituximab vs teriflunomide, according to an abstract being presented by investigators at the Multiple Sclerosis Centers (CMSC) annual meeting, being held June 1, 2022, to June 4, 2022.

Ukoniq generated $6.5 million in total net through its launch for the lymphoma indications in February 2021 through the end of fourth quarter 2021, about 10 months, according to the company earning release.

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