FDA Withdraws Umbralisib Approval for Lymphomas

The U.S. Food and Drug Administration has withdrawn its approval for umbralisib, which was approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL).

In April, the drug’s developer, TG Therapeutics, announced a voluntary withdrawal of the Biologics License Application/supplemental New Drug Application for the combination of umbralisib with ublituximab for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) based on updated overall survival data from the phase III UNITY-CLL trial that showed an increasing imbalance in overall survival.

Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving the drug. The FDA determined the risk of treatment with umbralisib outweigh its benefits. The developer has now voluntarily withdrawn the drug from the market for MZL and FL as well.

According to the FDA, health care professionals should stop prescribing umbralisib and switch patients to alternative treatments. Inform patients currently taking umbralisib of the increased risk of death seen in the clinical trial and advise them to stop taking the medicine. In limited circumstances in which a patient may be receiving benefit from umbralisib, TG Therapeutics plans to make it available under expanded access.

Source: FDA Safety Communication, June 2022