The FDA has just approved brentuximab vedotin to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy, an approval that “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 FDA’s Center for Drug Evaluation and Research Office of Hematology and Oncology Products.
The American Cancer Society estimates that 8500 people in the U.S. will be diagnosed with Hodgkin lymphoma in 2018 and approximately 1,050 patients will die from the disease.
Brentuximab vedotin works to target lymphoma cells known as CD30. It was previously approved by the FDA to treat classical Hodgkin lymphoma after relapse and classical Hodgkin lymphoma after stem cell transplant (for patients at high risk of relapse or progression), as well as other lymphomas after first-line therapy treatment failure.
This approval for adult patients with previously untreated stage III or IV cHL was based on a clinical trial comparing brentuximab vedotin plus chemotherapy to a chemotherapy-only regimen common for classical Hodgkin lymphoma. The trial measured the length of time it took for the disease to progress, death to occur, or new therapy to be initiated in patients who did not achieve a complete response.
In the trial of 1,334 patients, those treated with brentuximab vedotin plus chemotherapy were 23 percent less likely to experience progression, death, or treatment failure compared with those receiving chemotherapy alone. In the study, 18% of patients on the brentuximab vedotin plus chemotherapy did experience disease progression, death, or second line treatment compared to 22% of patients on chemotherapy. 67 percent of patients in this trial treated with brentuximab vedotin plus chemotherapy experienced peripheral neuropathy.
Common side effects of brentuximab vedotin include low white blood cell count, anemia, nerve pain, nausea, fatigue, constipation, diarrhea, vomiting, and fever.
Despite the side effects, however, Dr. Pazdur said this new treatment represents a new treatment choice for certain patients with the disease. “This approval demonstrates our commitment to approving advancements in treatment that give prescribers and patients different options for care.” For more on this recent FDA approval visit https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601935.htm.
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