NEW YORK – The European Commission on Wednesday approved Takeda and Seagen's Adcetris (brentuximab vedotin) plus chemotherapy as a treatment for newly diagnosed, CD30-positive stage III Hodgkin lymphoma patients.
The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) last month. The EC's decision is based on updated overall survival results from the Phase III ECHELON-1 study in which investigators pitted Adcetris plus doxorubicin, vinblastine and dacarbazine (AVD) against doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
After six years, 93.9 percent of patients who received Adcetris plus AVD were alive, versus 89.4 percent of patients who received ABVD. The progression-free survival rates after six years were 82.3 percent versus 74.5 percent, respectively.
Seagen markets Adcetris in the US and Canada, while Takeda markets it in other parts of the world. The antibody-drug conjugate is already commercially available in Europe and in the US for patients with CD30-positive Hodgkin and non-Hodgkin lymphomas including previously treated stage IV Hodgkin lymphoma, treatment-naïve cutaneous T-cell lymphoma, and previously treated systemic anaplastic large cell lymphoma.