On Friday, the FDA announced that brentuximab vedotin (Adcetris) has been approved for the treatment of Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL). In July, the drug had been unanimously recommended for accelerated approval by the FDA’s Oncologic Drug Advisory Committee.
Brentuximab vedotin is an antidrug conjugate containing an anti-CD30 monoclonal antibody. The drug selectively targets CD30, an important genetic marker in classic lymphoma and anaplastic large cell lymphoma, while sparing nearby normal cells that do not express the marker. It has been approved to treat HL in patients who have relapsed after receiving autologous stem cell transplant therapy and in patients with sALCL who have relapsed after undergoing at least 1 prior chemotherapy treatment.
It is the first new FDA-approved treatment for HL since 1977 and the first approved specifically for the treatment of ALCL.
“Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy,” said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, in a statement released on Friday.
Richard Pazdur, MD
Image courtesy of ASCO
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