ARTICLE | Regulation

Beat the clock

SGEN, FDA must agree on confirmatory trials for Adcentris in lymphoma by Aug. 30

July 18, 2011 7:00 AM UTC

FDA appears ready to grant Seattle Genetics Inc. accelerated approval for its Adcetris brentuximab vedotin, but the biotech only has until the Aug. 30 PDUFA date to reach an agreement with the agency on the appropriate confirmatory trials for the antibody-drug conjugate, else it will face another Oncologic Drugs Advisory Committee meeting.

Last week in two separate sessions, the Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend accelerated approval of Adcetris to treat patients with Hodgkin's lymphoma who relapse after autologous stem cell transplant and to treat patients with systemic anaplastic large cell lymphoma (ALCL)...