Generic name:umbralisib
Dosage form: tablets
Drug class:Multikinase inhibitors
- On June 1, 2022, the U.S. Food and Drug Administration (FDA) announced the withdrawal of the approval for Ukoniq (umbralisib) due to safety concerns.
- Updated findings from the UNITY-CLL clinical trial had continued to show a possible increased risk of death in patients receiving Ukoniq.
- It was determined that the risks of treatment with Ukoniq outweigh the benefits.
- As a result, TG Therapeutics announced the voluntarily withdrawal of Ukoniq from the market for the approved uses in MZL and FL.
What is Ukoniq?
Ukoniq is a prescription medicine used to treat adults with:
- Marginal zone lymphoma (MZL) when the disease has come back or did not respond to treatment and who have received at least one certain type of prior treatment.
- Follicular lymphoma (FL) when the disease has come back or did not respond to treatment and who have received at least three prior treatments.
It is not known if this medicine is safe and effective in children.
Warnings
Ukoniq can cause serious side effects, including:
- Infections. Ukoniq can cause serious infections that may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, flu-like symptoms, or any other signs of infection during treatment.
- Low white blood cell count (neutropenia). Neutropenia is common with Ukoniq treatment and can sometimes be serious. Your healthcare provider will check your blood counts regularly during treatment. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment.
- D...
