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Brentuximab vedotin plus CHP is approved by the European Commission and China for the treatment of adult patients with sALCL

May 20, 2020

On May 14, 2020, brentuximab vedotin in combination with cyclophosphamide, doxorubicin, prednisone (CHP) was granted an extension on the current conditional marketing authorization by the European Commission for treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). Brentuximab vedotin has previously received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. 1

The European Commission approval was based on positive data from ECHELON-2 phase III trial ( NCT01777152 ). The trial evaluated brentuximab vedotin plus CHP vscyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as first-line treatment in patients with CD30 +peripheral T-cell lymphoma, which included the sALCL subtype. The ECHELON-2 trial met its primary endpoint and demonstrated a statistically significant improvement in progression-free survival with brentuximab vedotin plus CHP (HR, 0.71; p = 0.0110). 1

The safety profile from the ECHELON-2 study was comparable between the two treatment arms and consistent with the established safety profile of brentuximab vedotin combined with chemotherapy. 1

China

Brentuximab vedotin has also been granted fast-track approval by China’s National Medical Products Administration for the treatment of adult patients with relapsed or refractory sALCL or CD30 +Hodgkin lymphoma. The approval was also based on the results from the ECHELON-2 trial. 2

  1. Pipeline Review. European Commission approves ADCETRIS® (brentuximab vedotin) for treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma. https://pipelinereview.com/index.php/2020051474636/Antibodies/European-Commission-Approves-ADCETRIS-brentuximab-vedotin-for-Treatment-of-Adult-Patients-with-Previously-Untreated-Systemic-Anaplastic-Large-Cell-Lymphoma.html. Published May 14, 2020. Accessed May 18, 2020.
  2. Pharmaceutical Technology. Takeda receives China approval for Adcetris to treat lymphoma. https://www.pharmaceutical-technology.com/news/takeda-adcetris-china-ec-approval/. Published May 15, 2020. Accessed May 18, 2020.