As the first of its kind, Adcetris (generic: brentuximab vedotin) is a revolutionary antibody-drug conjugate (ADC) specifically designed to treat Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL). While studies have shown success in the treatment of such conditions, the use of Adcetris is not without concern. Patients who receive Adcetris treatment may significantly increase their risk of having severe, life-threatening complications. Reports indicate that Adcetris may coincide with the development of progressive multifocal leukoencephalopathy (PML), a potentially fatal brain infection.
If you or a loved one has been injured by Adcetris, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Adcetris PML Brain Infection Lawsuit Overview
Relatively new to the pharmaceutical industry, Adcetris was developed by Seattle Genetics on August 19, 2011. Following mandatory regulatory actions, the U.S. Food and Drug Administration (FDA) approved the use of Adcetris to treat Hodgkin lymphoma and systemic anaplastic large cell lymphoma. Through a revolutionary mechanism of action, Adcetris targets the specific cells responsible for such conditions and prohibits further actions.
Adcetris is an antibody-drug conjugate directed towards CD30-expressing cells and is the first therapeutic advancement for Hodgkin lymphoma in 30 years. The active ingredient responsible for these actions is brentuximab vedotin. As an antibody-drug conjugate, brentuximab vedotin has the inherent ability to attach itself to the surface of malignant CD30 cells. Though the mechanism of action remains ambiguous in nature, the interaction is responsible for significant anti-tumor activity. By introducing brentuximab vedotin to cancerous cells, patients may experience a significant reduction and remission in the presence of Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
Unfortunately, recent evidence suggests a link between Adcetris and severe, life-threatening complications. Researchers believe that the pharmacodynamics of Adcetris may be responsible for the development of several complications with varying degrees of severity. More specifically, patients who use Adcetris may significantly increase their risk of developing progressive multifocal leukoencephalopathy and pulmonary toxicity. Due to the severity of these complications, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential Adcetris Brain Infection lawsuit.
Adcetris Side Effects
The following is a comprehensive list of Adcetris side effects:
- Fatigue
- Severe headache
- Chills
- Pain
- Edema peripheral
- Upper respiratory tract infection
- Nausea
- Diarrhea
- Abdominal pain
- Rash
- Dyspnea
- Pain in extremities
- Muscle spasms
Though these Adcetris side effects may interfere with an individual’s quality of life in a profound way, they are not considered life-threatening. They may, however, serve as indicators for more severe complications that coincide with the use of Adcetris.
Adcetris PML Brain Infection
According to an FDA Safety Announcement, two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the use of the lymphoma drug Adcetris. The signs and symptoms of PML may develop over the course of several weeks or months. They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body. Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label.
PML typically has a mortality rate between 30-50% in the few months following the initial diagnosis, but the long-term outlook largely depends on the severity of the underlying disease and treatment received. Those who manage to survive PML are usually left with severe lifelong neurological disabilities.
Adcetris PML Brain Infection Cases
According to an FDA Safety Communication, three patients have developed PML while receiving treatment with Adcetris.
A 48 year old man with Hodgkin lymphoma was diagnosed with PML after receiving Adcetris. After the third Adcetris treatment, he exhibited a significant increase in left-sided weakness and slurred speech. Accordingly, his cerebrospinal fluid tested positive for John Cunningham (JC) virus. The patient’s condition deteriorated rapidly resulting in death within four weeks of onset of symptoms.
Subsequently, a 50 year old man with Hodgkin lymphoma was diagnosed with PML after receiving Adcetris treatment. Following his eighth Adcetris treatment, he admitted himself to a local emergency room where he complained about significant changes in his speech, difficulty writing with his right hand, and right lower extremity weakness. The patient also exhibited signs of poor coordination, poor balance, and left-sided sensory deficits. Following multiple tests, a spinal cord lesion biopsy acknowledged the presence of the JC virus. The patient’s neurological condition continues to worsen, and most recently he lost motor function of his lower extremities and deep tendon reflexes of his legs. He also has tremulousness of his hands and hypoactive arm reflexes.
A 38 year old female patient with a history of anaplastic large cell lymphoma was diagnosed with PML after receiving Adcetris. After having received two Adcetris treatments, she complained of her inability to read, inability to find words to express herself, memory lapses, and slight loss of balance. A brain MRI revealed a demyelinating process and a brain biopsy was positive for JC virus.
Do I Have an Adcetris PML Brain Infection Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Adcetris PML brain infection lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Adcetris, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.