Wednesday, June 22, 2011

Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee
Meeting on July 14, 2011, from 8 a.m. to 5 p.m.

Agenda: On July 14, 2011, during the morning session, the committee will discuss biologics license application (BLA) 125388, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory (resistant to previous standard treatments) Hodgkin’s lymphoma. During the afternoon session, the committee will discuss BLA 125399, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma.

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