Adcetris Approval Expanded to Include Later-Stage Hodgkin Lymphoma
TUESDAY, March 20, 2018 -- U.S. Food and Drug Administration approval of Adcetris (brentuximab vedotin) has been expanded to include adults with untreated stage III or IV classical Hodgkin lymphoma, the agency said Tuesday in a news release.
The drug was first approved to treat Hodgkin lymphoma in 2011 and has been granted a number of additional approvals.
"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 Dr. Richard Pazdur, director of the agency's Oncology Center of Excellence.
Lymphoma is a form of cancer that often originates in the body's germ-fighting lymph system. With this type, there are large, abnormal white blood cells called Reed-Sternberg cells. With early intervention, long-term remission frequently is possible, the FDA said.
Some 8,260 people in the United States were diagnosed in 2017 with Hodgkin lymphoma, and more than 1,000 people died from it last year, the National Cancer Institute reported.
Common side effects of Adcetris include a shortage of blood cells, nerve damage of the hands and feet, nausea, fatigue, irregularity, vomiting and fever. The drug has a boxed label warning of greater-than-usual risk of a condition called John Cunningham viral infection, which could lead to a rare but deadly brain infection called PML.
Since Adcetris could harm a developing fetus, women who are pregnant or could be pregnant should avoid the drug, the FDA said.
Adcetris is produced by Seattle Genetics of Bothell, Wash.
Visit the FDA to learn more.
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Posted: March 2018