The FDA Withdraws Approval for Ukoniq (Umbralisib).
On June 1, 2022, the U.S. Food and Drug Administration (FDA) withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns. Ukoniq had been approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL).
According to the FDA, the risks of treatment with Ukoniq outweigh its benefits. Therefore, TG Therapeutics, the drug’s manufacturer, announced that it was voluntarily withdrawing Ukoniq from the market for use in MZL and FL cases.
On February 3, 2022, the FDA published a Drug Safety Communication that announced the agency’s investigation of increased risks of death with Ukoniq. Findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq.
Parker Waichman LLP, an award-winning national products liability law firm, is currently reviewing and investigating potential claims against the manufacturer, marketers, and distributors of Ukoniq. If you or a member of your family was harmed or if you lost a loved one due to Ukoniq complications, contact our firm to see if your case qualifies for financial compensation. Call Parker Waichman LLP today at 1-800-YOUR-LAWYER (1-800-968-7529) or fill out our online contact form for your free consultation.
Ukoniq is an oral medication that inhibits both casein kinase 1 (CK1) epsilon and phosphoinositide 3 kinase (PI3K) delta. PI3K-delta helps to support cell survival and proliferation, intercellular trafficking, cell differentiation, and the immune system. CK1-epsilon manages oncoprotein translation. Ukoniq had been approved for use to treat two types of lymphoma. The FDA approved Ukoniq in February 2021 under accelerated approval due to the drug’s overall response rate. However, the continued approval of Ukoniq depended on the verification of clinical benefit through a confirmatory clinical study. The FDA concluded that the benefit did not outweigh the risk.
According to the FDA, it initiated an investigation of a potential increased risk of death in patients taking Ukoniq (umbralisib) to treat the two types of lymphoma. The FDA announced in February 2022 that initial Ukoniq clinic trial results found a potential “increased risk of death” in patients taking Ukoniq. Moreover, the FDA stated that because of the seriousness of this safety issue and the similitudes between the types of cancer Ukoniq was approved and the kind of cancer that is being researched in the clinical trial, the FDA alerted patients and health care professionals to re-evaluate the risk of death against any benefits of Ukoniq for its authorized uses.
In June 2022, the FDA specifically urged physicians to “stop prescribing Ukoniq and switch patients to alternative treatments” and to “inform patients currently taking Ukoniq of the increased risk of death seen in the clinical trial and advise them to stop taking the medicine.”
The FDA recommended that patients dispose of all unused umbralisib. In special instances , TG Therapeutics has indicates that it will make umbralisib available under its expanded access program. Patients should speak with their health care professionals about the dangers and advantages of continuing with Ukoniq as well as any alternative treatments.
Prescription medicine Ukoniq was approved by the FDA in February 2021 to treat adult patients diagnosed with Marginal Zone Lymphoma (MZL) after the disease fails to respond to previous treatment with one or more specific types of medication or the disease has recurred. The FDA also approved Ukoniq to treat adults diagnosed with follicular lymphoma (FL) when the disease fails to respond to three or more prior treatments or the disease has returned. Both FL and MZL are slow-growing cancers that form inside white blood cells (lymphocytes). Ukoniq is in a class of drugs called PI3 kinase inhibitors. These medications work by blocking an abnormal protein from signaling cancer cells to multiply. The medication has been shown to help stop the spread of certain cancer cells. Ukoniq is a tablet that is taken orally.
According to the FDA, the agency conducted a data review from UNITY, a phase 3 controlled and randomized clinical trial involving patients diagnosed with chronic lymphocytic leukemia (CLL). The UNITY trial evaluates the use of Ukoniq with a monoclonal antibody drug designed to target CD20 proteins as compared to patients in a control group that receive a standard treatment. The study’s results revealed a probable increased risk of death in patients who received the combination of the monoclonal antibody and Ukoniq as compared to the control group. Patients taking the monoclonal antibody and Ukoniq combination also encountered more severe adverse events than patients in the control group.
The UNITY study was also conducted on CLL patients. Currently, Ukoniq is not approved for use on CLL patients. However, Ukoniq is being studied for use on CLL patients. The FDA is only concerned about the safety signals that apply to MZL and FL patients at this time. However, the FDA states these clinical trials show that other drugs that are in the same PI3 kinase inhibitor class have shown similar safety problems and will be investigated.
GROUNDS FOR FILING AN UKONIQ LAWSUIT
Monetary compensation for defective and dangerous medications is founded on the legal theory of product liability. The legal system usually recognizes three types of arguments in product liability cases: design defects, manufacturing defects, and failure to warn.
Design Defects: Design defects correlate to how the manufacturer created plans for the product, the nature and quality of the ingredients and parts used to manufacture the products, and how those components were meant to work together.
Manufacturing Defects: A manufacturing defect involves the manufacturing procedures that create a defective product. The production line might be flawed, or the defects might be restricted to a specific lot made during a certain period.
Failure to Warn: Drug manufacturers have a legal duty to warn consumers and the federal government about potential side effects, so the patient and their treating physician are able to make an informed decision.
SHOULD YOU PURSUE AN UKONIQ LAWSUIT?
If you or a loved one has suffered adverse side effects while taking Ukoniq, please seek medical attention and then contact Parker Waichman LLP for your free case evaluation. Parker Waichman LLP helps people harmed by dangerous drugs determine if they are able to file a Ukoniq lawsuit to recover monetary compensation for their injuries. Our Ukoniq lawyers are committed to making the manufacturers and marketers of dangerous products pay for their negligence.
WHAT DAMAGES MIGHT BE AVAILABLE IN AN UKONIQ LAWSUIT?
Each Ukoniq case is unique, so no one can’t assume that they will receive the same compensation as someone else’s case. However, a Ukoniq lawyer from our firm can help you and your family seek economic and non-economic damages. By way of example only, the following damages could be recovered through defective drug litigation:
Medical Expenses: Medical expenses may include compensation for medical treatment, doctor visits, travel expenses, and any other expenses directly caused by Ukoniq injuries.
Pain and Suffering: Compensation for pain and suffering that the victim endured connected to Ukoniq.
Punitive Damages: The court may permit punitive damages to be awarded in the case if the manufacturer committed fraud or some other intentional act that harmed the victim.
PARKER WAICHMAN LLP?
Parker Waichman LLP is an award-winning, national product liability law firm whose attorneys have earned a reputation as relentless advocates who fight for victims. Our product liability law firm is based in New York but represents clients throughout the United States.
The legal community has bestowed several honors on our firm, including:
- A 9.8 (out of a perfect 10) rating by AVVO
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FREE CONSULTATION WITH OUR UKONIQ LAWYERS TODAY
If you or a loved one suffered harm while taking Ukoniq, or if you lost a loved one who was taking Ukoniq, contact us for a free case review. An attorney with our defective drug litigation firm will evaluate your potential claim. Call Parker Waichman LLP today at 1-800-YOUR-LAWYER (1-800-968-7529) or fill out our online contact form for your free consultation.
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