The US Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin) as a treatment for certain adult patients with classical Hodgkin lymphoma (cHL). Under the latest approval, the Seattle Genetics drug is indicated for use in combination with chemotherapy as a treatment for patients with previously untreated stage III or stage IV cHL.
Approval for Adcetris was granted following a clinical trial comparing the effectiveness of treatment with Adcetris and chemotherapy, with a chemotherapy-only treatment regimen. The trial of 1,334 patients found those receiving chemotherapy using Adriamycin (doxorubicin), vinblastine and dacarbazine as well as Adcetris were 23 percent less likely to die, experience a progression of the disease, or the initiation of a new therapy.
“Today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. The approval of Adcetris demonstrates the FDA’s commitment to giving prescribers and patients more treatment options, he added.
What is classical Hodgkin lymphoma?
Hodgkin’s lymphoma is a cancer of the lymphatic system that develops when lymphocytes (infection-fighting cells) develop genetic mutations. Classical Hodgkin lymphoma is the more common form of Hodgkin’s lymphoma and it is characterized by large abnormal cells called Reed-Sternberg cells in the lymph nodes.
There are a number of different forms of classical Hodgkin lymphoma, including nodular sclerosis, mixed cellularity, lymphocyte-depleted, and lymphocyte-rich Hodgkin’s lymphoma. Each year, around 8,500 people in the United States are diagnosed with Hodgkin’s lymphoma.
What is Adcetris?
Adcetris is a combination of an antibody and a drug. It functions by enabling the antibody to direct the drug to target the lymphoma cells. It already has FDA approval as a treatment for cHL following a relapse, or after a stem cell transplant in which patients are at a high risk of relapse or progression. It is also indicated to treat systemic anaplastic large cell lymphoma following treatment failure, as well as primary cutaneous anaplastic large cell lymphoma after failure of another treatment option.
Common Side Effects of Adcetris:
- Low white blood cell count
- Low red blood cell count
- Tingling or numbness in the hands or feet
Several serious side effects are also associated with Adcetris, including peripheral neuropathy, allergic and infusion reactions, blood problems, serious infections, tumor lysis syndrome, liver injury, lung problems, skin problems, and gastrointestinal problems. Adcetris should not be taken by pregnant women and physicians should be informed of any existing medical conditions, particularly severe kidney or liver disease.
Adcetris also carries a boxed warning about the risk of John Cunningham virus infection leading to progressive multifocal leukoencephalopathy, a rare but severe brain infection that can prove fatal.
Other treatment options for cHL
Hodgkin’s lymphoma is a treatable condition, particularly when caught in the early stages. Common treatment options include chemotherapy, radiation therapy, bone marrow transplants and drug therapies. Medications used to treat Hodgkin’s lymphoma include bleomycin, doxorubicin, Leukeran , and methotrexate.
For more information on Adcetris, visit: http://adcetrisavd.com