According to a news report posted on MedPageToday.com, the U.S. Food and Drug Administration is concerned about “excess mortality” during a drug trial of umbralisib/ublituximab (Ukoniq). The FDA published a public notice that reports preliminary data from a clinical trial suggests “an increased mortality risk” in patients treated with Ukoniq, a PI3K inhibitor.
The FDA also announced that the agency had opened an investigation into the efficacy and safety of the lymphoma drug umbralisib (Ukoniq). The U.S. Food and Drug Administration’s Drug Safety Communication states that umbralisib has already been approved to treat two types of lymphomas. The FDA is warning health care professionals and patients that the agency is re-evaluating the risks and benefits of Ukoniq for its authorized uses because of the agency’s concern.
The FDA is continuing to examine the clinical trial results. The FDA may hold a public meeting to report on these discoveries and explore the continued sale of Ukoniq. According to the FDA, they have suspended new patient enrollment into ongoing clinical trials of Ukoniq. The suspension will continue while the FDA reviews the clinical trial results.
Health care professionals are being asked to review patients’ progress on Ukoniq and explain the risks and benefits of taking Ukoniq in the context of other alternative therapies.
Patients are urged to contact health care professionals to discuss the benefits and risks of Ukoniq. Patients taking Ukoniq should talk to their doctor about 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.
The FDA is urging patients and health care professionals to report any Ukoniq side effects to the FDA MedWatch program.
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