Hatim al-Awni

European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD

Retrieved on: 
Wednesday, October 18, 2023

Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.
  • ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in Europe in six distinct indications, including those with previously untreated CD30+ Stage IV Hodgkin lymphoma.
  • The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 14, 2023.
  • “We are thrilled with the decision of the European Commission to approve ADCETRIS in combination with chemotherapy as a treatment for adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma, particularly as up to one third of patients with Stage III & IV disease are at risk of experiencing treatment failure with current regimens,” said Awny Farajallah, M.D., head of global medical affairs oncology, Takeda.