On June 1, 2022, the the U.S. Food and Drug Administration (FDA) announced withdrawal of its approval for Ukoniq (umbralisib), a cancer medication previously approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL). The FDA Ukoniq investigation continues.
According to a news report posted on MedPageToday.com, the FDA has been concerned about “excess mortality” during a drug trial of umbralisib/ublituximab (Ukoniq). The FDA published a public notice in Febriary 2022, reporting preliminary data from a clinical trial suggests “an increased mortality risk” in patients treated with Ukoniq, a PI3K inhibitor.
The FDA also announced in February 2022 that the agency had opened an investigation into the efficacy and safety of the lymphoma drug umbralisib (Ukoniq). The FDA’s Drug Safety Communication stated that umbralisib had already been approved to treat two types of lymphomas. The FDA warned health care professionals and patients that the agency was re-evaluating the risks and benefits of Ukoniq for its authorized uses because of the agency’s concern. The FDA also suspended new patient enrollment into ongoing clinical trials of Ukoniq at that time, pending Ukoniq FDA review of the clinical trial results.
After completion of an FDA Ukoniq review in June 2022, the FDA announced that a possible increased risk of death in patients receiving Ukoniq outweighs its benefits. Based on that conclusion, TG Therapeutics, the drug’s maker, voluntarily withdrew the drug from the market for the approved uses in MZL and FL
The FDA has urged health care professionals to stop prescribing Ukoniq and switch patients to alternative treatments. Patients should stop taking Ukoniq and contact health care professionals to discuss other treatment options.
Ukoniq is a prescription drug approved to treat adults with marginal zone lymphoma (MZL) in February 2021. The medication is only prescribed when the disease has come back, or the patient’s lymphoma has not responded to other treatment options. The FDA has also approved Ukoniq to treat recurring follicular lymphoma. Both marginal zone lymphoma and follicular lymphoma are slow-growing cancers that form in white blood cells (lymphocytes).
Ukoniq is a PI3 kinase inhibitor that blocks abnormal protein action that instructs cancer cells to multiply. The medication is designed to help stop cancer cell spread. The medicine is manufactured in tablet form and is taken orally.
The FDA conducted its initial review of Ukoniq based on data produced from UNITY. UNITY is a randomized, phase 3 controlled clinical trial with study participants with chronic lymphocytic leukemia. The clinical trial has been assessing Ukoniq’s use with a monoclonal antibody drug that targets the CD20 protein. The study’s results showed a potential increased risk of death in patients who receive the combination of the monoclonal antibody and Ukoniq compared to the study’s control. Some patients who are receiving the combination of the monoclonal antibodies and the drug Ukoniq have experienced more serious adverse events than those who were in the control group. The UNITY trial findings had implications for additional approved uses. Clinical trials conducted on other medicines in the identical PI3 kinase inhibitor class as Ukoniq have also exhibited similar safety concerns. This prompted the FDA Ukoniq withdrawal.
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