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Rituximab biosimilar, riximyo, given ‘positive opinion’ by the EMA CHMP for use in Follicular and Diffuse Large B-Cell Lymphoma
On the 21st April 2017, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for granting marketing authorization for riximyo, a rituximab biosimilar monoclonal antibody targeting CD20 on B-cells.
The marketing approval application for riximyo was submitted by Sandoz GmbH. The CHMP concluded that riximyo shows “comparable quality, safety, and efficacy to Mabthera® (rituximab)” from Roche.
Riximyo will be available as 500mg and as a 100mg concentrate for solution for infusion. The full indication for riximyo is listed below:
Non-Hodgkin lymphoma (NHL)
- Riximyo is indicated for the treatment of previously untreated patients with stage III-IV FL in combination with chemotherapy
- Riximyo maintenance therapy is indicated for the treatment of FL patients responding to induction therapy
- Riximyo monotherapy is indicated for treatment of patients with stage III-IV FL who are chemo-resistant or are in their second or subsequent relapse after chemotherapy
- Riximyo is indicated for the treatment of patients with CD20 positive DLBCL in combination with CHOP chemotherapy
References
Your opinion matters
Which of the following would most increase your confidence in referring patients with R/R large B-cell lymphoma for CAR T-cell therapy?