Seattle Genetics Inc. has submitted a supplemental Biologics License Application to FDA based on data from the phase III ECHELON-2 trial evaluating Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.
In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.
