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Brentuximab vedotin receives positive CHMP opinion in combination with CHP as treatment for adult patients with previously untreated sALCL

Apr 2, 2020

On March 31, 2020, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)adopted a positive opinion for the extension of the marketing authorization for the anti-CD30 antibody–drug conjugate, brentuximab vedotin. The CHMP recommended its approval in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). 1

The CHMP decision was based on positive data from the phase III ECHELON-2 trial ( NCT01777152). The trial demonstrated favorable clinical activity of brentuximab vedotin plus CHP vscyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as first-line treatment in patients with CD30 +peripheral T-cell lymphoma (PTCL), which included the sALCL subtype. Treatment with brentuximab vedotin plus CHP improved progression-free survival by 29% compared to CHOP administration, with a comparable safety profile. 1

Read the Lymphoma Hub’s coverage of the ECHELON-2 trial here ,and watch Ranjana Advani discuss it below.

ECHELON-2 trial: response by CD30 expression

  1. PipelineReview. Takeda receives positive CHMP opinion for ADCETRIS in combination w/ CHP for adult patients with previously untreated sALCL. Published Apr 01, 2020. Accessed Apr 02, 2020.