Seattle Genetics files sBLA at FDA for Adcetris + chemotherapy for treatment of advanced classical Hodgkin lymphoma.

Seattle Genetics, Inc. announced that it has submitted a supplemental Biologics License Application (BLA) to the FDA based on data from the phase III ECHELON-1 trial evaluating Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma.

Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma. ADcetris is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials. Adcetris is currently not approved as a frontline therapy for Hodgkin lymphoma.

Comment: There have been no new treatment advances for frontline Hodgkin lymphoma in more than 40 years. Up to 30 percent of the patients diagnosed with advanced disease will experience disease progression after frontline treatment with the current standard of care chemotherapy regimen, representing a significant unmet need to improve the treatment outcome of these patients who are often young adults.