Seattle Genetics Hoping Adcetris Label Expansion Trials Can Be Confirmatory
Over the next six weeks Seattle Genetics intends to negotiate with FDA over its plans for confirmatory trials to support accelerated approval of Adcetris (brentuximab vedotin) – which the company hopes to accomplish using studies already planned as further development of the antibody-drug conjugate.
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FDA approves the antibody-drug conjugate for late stage Hodgkins lymphoma and systemic anaplastic large cell lymphoma Aug. 19.
Sponsors seeking insight into when a single-arm trial will be deemed acceptable support for accelerated approval by FDA and its Oncologic Drugs Advisory Committee can look to the recent review of Seattle Genetics’ Adcetris (brentuximab) for clues.