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FDA Schedules ODAC Meeting for Rituximab Biosimilar

Jason M. Broderick @jasoncology
Published: Wednesday, Sep 12, 2018

Woosung Kee

Woosung Kee

The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) hearing for October 10, 2018, to discuss a biologics license application (BLA) for CT-P10, a proposed biosimilar to rituximab (Rituxan).

Rituximab has approved indications for FL, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.
Kim WS, Jurczak W, Sancho J-M, et al. Double-blind, randomized phase 3 study to compare efficacy and safety of the biosimilar CT-P10 to rituximab combined with CVP therapy in patients with previously untreated advanced-stage follicular lymphoma. J Clin Oncol. 2018;36 (suppl; abstr 7532).

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