Dr. Goy Discusses the Rituximab Biosimilar FDA Approval

Andre Goy, MD, MS
Published: Wednesday, Nov 28, 2018



Andre Goy, MD, MS, chief, Division of Lymphoma, chairman and director, John Theurer Cancer Center, discusses the FDA approval of the rituximab (Rituxan) biosimilar, CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy.

The indications in NHL include relapsed/refractory, low-grade or follicular lymphoma, CD20-positive B-cell NHL as a single agent; previously untreated follicular lymphoma, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and non-progressing or stable low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone chemotherapy.

This is the first approval for a rituximab biosimilar in the United States.
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Andre Goy, MD, MS, chief, Division of Lymphoma, chairman and director, John Theurer Cancer Center, discusses the FDA approval of the rituximab (Rituxan) biosimilar, CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy.

The indications in NHL include relapsed/refractory, low-grade or follicular lymphoma, CD20-positive B-cell NHL as a single agent; previously untreated follicular lymphoma, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and non-progressing or stable low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone chemotherapy.

This is the first approval for a rituximab biosimilar in the United States.

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: Evaluating the Emerging Role of Biosimilar Agents for the Treatment of Hematologic MalignanciesMar 08, 20193.0
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