Adcetris Indication Expanded
August 17, 2015 – The U.S. Food and Drug Administration (FDA) granted a third indication for Adcetris (brentuximab vedotin) manufactured by SeattleGenetics to treat classical Hodgkin lymphoma patients who have a high risk of disease returning or worsening after transplant of their own hematopoietc (blood-forming) stem cells. Adcetris had been indicated for classical Hodgkin patients who have suffered a relapse after either a stem-cell transplant or treatment with two other chemotherapy drug regimens. It was also granted an accelerated approval to treat patients who have systemic anaplastic large cell lymphoma (sALCL) that has not responded to one or more previous drug treatment combinations. Recommended dose of Adcetris is 1.8mg per Kg of body weight administered once every three weeks by intravenous (IV) infusion. Treatment should begin four to six weeks after the transplant and should continue for up to 16 three-week cycles. Boxed warnings for Adcetris Labels must address progressive multifocal leukoencephalopathy (PML), a potentially deadly but rare viral infection of the brain, which has occurred among patients who use it.
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