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On 12th September 2017, the Biologics License Application (BLA) submitted by Sandoz (Novartis) for Rixathon (GP2013; rituximab biosimilar) to the U.S. Food and Drug Administration (FDA) was accepted.
The BLA was supported by data from the phase III confirmatory ASSIST-FL study (NCT01419665), which aimed to compare the efficacy and safety, as well as the Pharmacokinetics (PK) and Pharmacodynamics (PD), of cyclophosphamide, vincristine, and prednisone combined with either Rixathon (GP2013-CVP) or rituximab (R-CVP) in patients with newly diagnosed, advanced stage FL (n=629).
If approved, the indications for Rixathon will include Follicular Lymphoma (FL), Diffuse Large B-Cell Lymphoma (DLBLC), and Chronic Lymphocytic Leukemia (CLL). The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for Rixathon in April 2017 (read more here), and this was followed by European approval in June.
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