The US Food and Drug Administration (FDA) has granted accelerated approval to Seattle Genetics’ Adcetris (brentuximab vedotin) as a treatment for Hodgkin’s lymphoma after failure of autologous stem cell transplant and systemic anaplastic large cell lymphoma.
Adcetris, an antibody-drug conjugate, comprises an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E, using Seattle Genetics’ proprietary technology.
The approval is based on data from two open-label, single-arm clinical trials, consisting of a 102-patient pivotal trial in Hodgkin’s lymphoma patients who relapsed after ASCT and a 58-patient pivotal trial in relapsed systemic anaplastic large cell lymphoma patients.
In the Hodgkin’s lymphoma clinical trial, 73% of patients achieved an objective response following treatment with Adcetris, including 32% with complete remission and 40% with partial remission, while in the systemic anaplastic large cell lymphoma clinical trial, 86% of patients achieved an objective response, including 57% with complete remission.
