The European Commission has granted approval for the use of Takeda and Seagen’s Adcetris (brentuximab vedotin) in combination with chemotherapy as a treatment for newly diagnosed, CD30- positive stage III Hodgkin lymphoma patients. This significant regulatory milestone follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in the preceding month. The decision by the European Commission is based on updated overall survival data from the Phase III ECHELON-1 clinical trial, where researchers compared the efficacy of Adcetris in combination with doxorubicin, vinblastine, and dacarbazine (AVD) against the standard treatment regimen of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
After six years of follow-up, the data revealed compelling outcomes for the patients who received Adcetris plus AVD. A remarkable 93.9 percent of these patients were still alive, compared to 89.4 percent of those who received ABVD. Additionally, progression-free survival rates after six years were notably superior in the Adcetris plus AVD group, with a rate of 82.3 percent, compared to 74.5 percent among patients treated with ABVD.
Adcetris, an antibody-drug conjugate, is jointly marketed by Seagen in the United States and Canada, while Takeda handles its marketing in other parts of the world. This recent approval in Europe expands the scope of Adcetris’ availability, which was already commercialized for the treatment of CD30-positive Hodgkin and non-Hodgkin lymphomas in Europe and the United States. The approved indications include its use in previously treated stage IV Hodgkin lymphoma, treatment-naïve cutaneous T-cell lymphoma, and previously treated systemic anaplastic large cell lymphoma.
This decision by the European Commission underscores the growing recognition of Adcetris as an effective and potentially life-saving therapy for Hodgkin lymphoma patients. By combining Adcetris with AVD chemotherapy, healthcare professionals now have an additional and highly promising treatment option for newly diagnosed CD30-positive stage III Hodgkin lymphoma, further contributing to the advancement of cancer care and improved patient outcomes in Europe.