Dr. Goy Discusses the Rituximab Biosimilar FDA Approval

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.