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Brentuximab Vedotin Nears European Approval for CTCL

Jason Harris
Published: Tuesday, Nov 14, 2017

Julia Scarisbrick, MD

Julia Scarisbrick, MD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of brentuximab vedotin (Adcetris) in adults with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy, Takeda Pharmaceuticals, which codevelops the antibody-drug conjugate with Seattle Genetics.

AE-related discontinuations occurred in 24% of patients in the brentuximab vedotin arm and 8% of patients in the physician’s choice arm. There were 4 patient deaths in the brentuximab vedotin arm, 3 of which were considered unrelated to treatment. No patients died on-study in the control arm.
References
  1. Kim YH, Whittaker S, Horwitz SM, et al. Brentuximab vedotin demonstrates significantly superior clinical outcomes in patients with CD30-expressing cutaneous T cell lymphoma versus physician's choice (methotrexate or bexarotene): the phase 3 ALCANZA study. Presented at: 58th Annual ASH Annual Meeting; December 3-6, 2016; San Diego, CA. Abstract 182.
  2. Prince HM, Kim YH, Horwitz SM, et al. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial [published online June 6, 2017]. Lancet. 2017 doi: 10.1016/S0140-6736(17)31266-7.

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