FDA expands approval of Seattle Genetics' Adcetris to include treatment for certain patients with advanced Hodgkin's lymphoma

Seattle Genetics on Tuesday announced that the FDA expanded approval of Adcetris (brentuximab vedotin) to include use in combination with chemotherapy in previously untreated adults with advanced Hodgkin's lymphoma. Seattle Genetics CEO Clay Siegall remarked "with today's FDA approval, the physician and patient community have a new treatment option for previously untreated stage III or IV Hodgkin lymphoma patients."

Approval of Adcetris for stage III or IV classical Hodgkin lymphoma (cHL) was supported by efficacy and safety data from the Phase III ECHELON-1 study, which included 1334 patients with advanced newly diagnosed cHL.  In the trial, top-line results of which were unveiled in June last year, with full data presented subsequently at the 2017 annual meeting of the American Society of Hematology (ASH), while also being published in the NEJM, the therapy, when used in combination with doxorubicin, vinblastine and dacarbazine (AVD), was linked to significant improvements in progression-free survival versus those treated with doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD). 

Specifically, the FDA indicated that patients treated with Adcetris plus AVD were 23 percent less likely to experience progression, death, or initiation of new therapy compared with those receiving ABVD. Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, remarked "today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago."

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Adcetris was granted breakthrough therapy designation by the FDA for the frontline treatment of patients with advanced cHL last October. The therapy was also awarded priority review by the agency in January.  

Adcetris, which is being jointly developed by Takeda under the terms of a 2009 agreement, was initially approved in the US for the treatment of patients with relapsed and refractory Hodgkin lymphoma and those with systemic anaplastic large cell lymphoma. The antibody-drug conjugate was subsequently authorised by the FDA for the treatment of patients with cHL at high risk of relapse or progression. 

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