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TG Therapeutics and Ukoniq
If you or a loved one took Ukoniq and suffered severe side effects or even death, you may be entitled to financial compensation. Talk to an AVA legal expert today and take your first step towards healing.
AVA Law Group
TG Therapeutics Puts Profit Over People by Rushing to Release a Dangerous Product in an Attempt to Corner the Market
On June 1, 2022, The US Food and Drug Administration withdrew its approval of TG Therapeutics’s most recent pharmaceutical Ukoniq.
The FDA approved Ukoniq in February 2021 as a cancer treatment for qualifying adults with marginal zone lymphoma and follicular lymphoma. However, as part of the FDA’s accelerated approval track, recent studies have shown an increased risk of death among patients using Ukoniq.
In a statement, the FDA stated that “[a]s a result, the FDA determined the risks of treatment with Ukoniq outweigh its benefits.” 1
At AVA Law Group, we continue to investigate claims that TG Therapeutics was negligent in rushing to release a deadly drug onto the market.
Here’s everything you need to know about what the sudden removal of Ukoniq from the market means for you.
What are B-Cells and What Do They Have to Do with Lymphoma
TG Therapeutics broke into the marketplace promising to treat b-cell diseases.
A b-cell is a subset of white blood cells found in the bone marrow and is essential for a healthy immune system. The b-cell works to identify potential infections invading the body. After binding to a virus or bacteria, the b-cell activates, making it easy for other white blood cells to identify and target whatever invades the body.
Like other cells, b-cells can become cancerous under the right conditions.
According to a TG company press release, some b-cell diseases, including lymphoma, “remain incurable diseases with limited treatment options for patients who relapse after prior therapy and no defined standard of care.” 2
According to TG Therapeutics, the initial clinical trial showed that Ukoniq was safe and effective for most study participants. In early 2021, the FDA approved Ukoniq as a treatment for qualifying patients with marginal zone lymphoma and follicular lymphoma.
What is Marginal Zone Lymphoma?
Marginal zone lymphoma (MZL) is a type of slow-growing cancer. Instead of being an inherited condition, MZL starts with a genetic mutation in b-cell DNA. According to the Cancer Treatment Centers of America, MZL can only originate in three areas of the body: lymph nodes, spleen, and lymphatic tissue. Scientists classify the three types of MZL based on where they initially occurred. 3
As with most cancers, the triggers that cause MZL’s genetic mutation can stem from several environmental factors.
Symptoms of MZL range from general to specific and include night sweats, fever, indigestion, Tiredness, enlarged spleen, etc.
Unfortunately, patients who have marginal zone lymphoma have few treatment options. Some medical interventions available include antiviral therapy, chemotherapy, and radiation therapy.
WHAT IS FOLLICULAR LYMPHOMA?
Follicular lymphoma is a b-cell lymphoma. Like marginal zone lymphoma, follicular lymphoma usually spreads slowly and is not genetic or passed down through families. Instead, it’s a genetic mutation of b-cell DNA.
According to the Cancer Treatment Centers of America, although follicular lymphoma usually originates in the b cell in the lymph nodes, “it may also metastasize to the bone marrow and/or spleen.” 4
Scientists continue to study what causes follicular lymphoma. Like marginal zone lymphoma, several environmental triggers probably cause the b-cells to mutate into this type of lymphoma. However, according to Cancer Treatment Centers of America, researchers believe that “exposure to pesticides and prior use of immunosuppressive therapy—and certain genetic influences may be at play.” 4
It’s not uncommon for follicular lymphoma to be asymptomatic. However, it’s common to experience swelling in the armpits, neck, groin, and abdomen. Like marginal zone lymphoma, symptoms of follicular lymphoma include fatigue, weight loss, and night sweats.
Follicular lymphoma is considered a chronic illness, and treatment options include radiation treatment, chemotherapy, and monoclonal antibody therapy.
What is Ukoniq and How Does It Work?
When Ukoniq first hit pharmacy shelves in 2021, TG Therapeutics marketed it as a revolutionary treatment for specific types of lymphoma. According to a TG Therapeutics 2021 press release in early 2021, the company celebrated the FDA’s accelerated approval for “the first and only, oral, once daily, inhibitor.” 2
Ukoniq is a PI3 kinase inhibitor that works by inhibiting the production of an abnormal protein that helps cells divide. By targeting these proteins, Ukoniq slows or even stops the growth rate of cancerous cells.
In the past, the FDA issued warnings over other PI3 kinase inhibitors. According to lawsuits.com, “In 2015, the FDA issued similar warnings about the cancer drug Zydelig.” 5
Unlike Zydelig, Ukoniq showed true potential in phase 1 trials.
However, TG’s miracle drug may not be as revolutionary as the company marketed. During further clinical studies, the FDA found “a possible increased risk of death in patients receiving Ukoniq.” 1
Following the FDA’s announcement, TG Therapeutics pulled Ukoniq from U.S. pharmacies.
How Can We Hold Big Pharma Accountable?
The story of TG Therapeutics and Ukoniq is not a new one. In today’s highly profitable pharmaceutical industry, manufacturers constantly push legal boundaries in a rush to put out the new miracle drug. Ukoniq is no exception.
TG Therapeutics put profit over people in a race to corner the b-cell disease marketplace. Due to the company’s negligence, people died, and their families suffered.
The cultural landscape around big pharma is shifting. Recent lawsuit victories have shown that people want to hold these companies accountable for the damage they’ve caused everyday Americans.
Consulting with an experienced attorney is essential when considering a lawsuit against any pharmaceutical company. Based on the specific details of your case, a knowledgeable lawyer can help you make critical decisions about where to file your lawsuit, who to pursue, if your case meets the time requirements for filing a suit, etc.
At AVA Law Group, we provide access to top-notch, experienced attorneys from across the U.S. with proven track records of success.
In addition to our high-quality legal staff, we value your story. Our legal team will work to ensure the courts hear your voice.
While we understand that a lawsuit will not reverse the damage caused to you and your family, financial restitution will go a long way to give you access to the care you need to start healing.
You deserve justice for the trauma you endured, and we promise to fight aggressively to protect your rights.
If you or a loved one took Ukoniq and suffered severe side effects or even death, you may be entitled to financial compensation.
Talk to an AVA legal expert today and take your first step towards healing.
AVA Law Group
WHAT TO DO IF YOU TAKE UKONIQ
The FDA is recommending that providers discontinue prescribing Ukoniq. Doctors should discuss the recent findings and risks with their patients and suggest alternative treatments.
If you are a patient taking Ukoniq, talk to your provider about current and future treatment plans.
The FDA recommends that patients and doctors report any lingering side effects.
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