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Rituximab biosimilar, rixathon, given ‘positive opinion’ by the EMA CHMP for use in Follicular and Diffuse Large B-Cell Lymphoma, and Chronic Lymphocytic Leukemia
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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 rixathon, a rituximab biosimilar monoclonal antibody targeting CD20 in B-cells.
The marketing approval application for rixathon was submitted by Sandoz GmbH. The CHMP concluded that rixathon shows “comparable quality, safety, and efficacy to Mabthera® (rituximab)” from Roche.
Rixathon will be available as a 500mg and as a 100mg concentrate for solution for infusion. The full indications for rixathon are listed below:
Non-Hodgkin Lymphoma (NHL)
- Rixathon is indicated for the treatment of previously untreated patients with stage III-IV FL in combination with chemotherapy
- Rixathon maintenance therapy is indicated for the treatment of FL patients responding to induction therapy
- Rixathon 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
- Rixathon is indicated for the treatment of patients with CD20 positive DLBCL in combination with CHOP chemotherapy.
Chronic Lymphocytic Leukemia (CLL)
- Rixathon in combination with chemotherapy is indicated for the treatment of patients with previously untreated and R/R CLL
- Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rixathon or patients’ refractory to previous rixathon plus chemotherapy
- Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rixathon or patients’ refractory to previous rixathon plus chemotherapy
- European Medicines Agency; Committee for Medicinal Products for Human Use. Summary of opinion (initial authorisation) – Rixathon (rituximab). 2017 Apr 21. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003903/WC500226219.pdf. [Accessed 2017 May 02].
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