Ukoniq Lawyer

After the U.S. Food and Drug Administration (FDA) withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns, people who took the drug may be concerned about possible Ukoniq side effects. Phillips Law Group is currently reviewing and looking into potential claims involving Ukoniq.

Ukoniq is a TG Therapeutics drug that was approved by the FDA in February 2021. It is used as a treatment for marginal zone lymphoma and follicular lymphoma. Unfortunately, FDA officials determined the risks of taking the drug outweigh the benefits of treatment.

Ukoniq was allowed on the market thanks to the FDA’s Accelerated Approval program. But after a review of data from a clinical trial meant to determine whether or not the use of the drug could be expanded for the treatment of chronic lymphocytic leukemia (CLL) when combined with the investigational monoclonal antibody drug, ublituximab, the FDA issued an Ukoniq drug safety communication, announcing it was withdrawing approval of the drug.

“Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq,” an FDA statement read. “Based upon this determination, the drug’s manufacturer, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market for the approved uses in marginal zone lymphoma and follicular lymphoma.”

The statement urged patients to talk to their healthcare professionals about alternative treatments and to stop taking Ukoniq, and for healthcare professionals to stop prescribing Ukoniq at all.

Both healthcare professionals and patients previously taking Ukoniq were asked to report adverse events or Ukoniq side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

If you or a loved one has suffered side effects after taking Ukoniq, please contact the team at Phillips Law Group for a free consultation to learn more about your potential legal options. The first, no-obligation case review with our office is free – you pay nothing unless we move forward with a case and you recover compensation.

Please call us at 602-222-2222 or fill out the form on this page to contact us.

What Is Ukoniq Used For?

According to the FDA, Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma and follicular lymphoma.

Why Did the FDA Withdraw Approval for Ukoniq?

Findings from a UNITY-CLL clinical trial showed a possible increased risk of death in patients receiving Ukoniq, so the FDA pulled approval for the drug. 

“The FDA determined the risks of treatment with Ukoniq outweigh its benefits,” a statement from the agency released in June 2022 read. 

“Based upon this determination, the drug’s manufacturer, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market for the approved uses in marginal zone lymphoma and follicular lymphoma.”

Has Ublituximab Been Approved?

The FDA rescinded its approval of Ukoniq after a phase 3 trial of the drug in combination with ubltiuximab in chronic lymphocytic leukemia and small lymphocytic leukemia was found to potentially increase the risk of death.

However, TG Therapeutics got approval for its monoclonal antibody ublituximab in December 2022. It is now called Briumvi, and the FDA has approved it for the treatment of relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, according to a press release from the company.

Should I Pursue a Ukoniq Case?

Phillips Law Group is currently reviewing and looking into potential claims involving Ukoniq. Please get in touch with our offices if you or a loved one has been impacted after taking Ukoniq. As a law firm dedicated to helping clients who have been harmed seek justice, we will discuss any possible legal steps you can take.