The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.
Common side effects of Adcetris include low levels of certain blood cells (neutropenia, anemia), nerve damage causing numbness or weakness in the hands and feet (peripheral neuropathy), nausea, fatigue, constipation, diarrhea, vomiting and fever (pyrexia). In the above clinical trial, 67 percent of patients treated with Adcetris plus chemotherapy experienced damage to the peripheral nervous system (peripheral neuropathy). In addition, neutropenia occurred in 91 percent of patients treated with Adcetris plus chemotherapy, which was associated with a 19 percent rate of febrile neutropenia (neutropenia and fever). Preventative treatment with G-CSF, a growth factor for the bone marrow to produce white blood cells, is recommended with Adcetris plus chemotherapy for the first-line treatment of Stage III or IV cHL
Adcetris has a boxed warning that highlights the risk of John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy, or PML, a rare but serious brain infection that can result in death.
Serious risks of Adcetris include peripheral neuropathy; severe allergic (anaphylaxis) or infusion-site reactions; damage to the blood, lungs and liver (hematologic, pulmonary and hepato-toxicities); serious or opportunistic infections; metabolic abnormalities (tumor lysis syndrome); serious dermatologic reactions and gastrointestinal complications. Adcetris can cause harm to a developing fetus and newborn baby; women should be advised of the potential risk to the fetus and to use effective contraception, and to avoid breastfeeding while taking Adcetris.
For more information please visit: Adcetris.