Biologics License Application for Rixathon (rituximab biosimilar) accepted for review by FDA

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).

Key Highlights:
  • Treatment phase = 6 months; maintenance phase = 2 years; follow-up = 3 years
  • Pts randomly assigned to 8 cycles of CP2013-CVP (n=314) or R-CVP (n=315)
  • Pts who achieved CR or PR entered the double-blind maintenance phase, and received either CP2013 or rituximab
  • ORR with GP2013-CVP was 87.1% (CR = 14.8%; PR = 72.3%) versus 5% (CR = 13.4%; PR = 74.1%) with R-CVP
  • Median PFS and OS have not been reached
  • PK and PD of Rixathon was similar to rituximab
  • Incidence of SAEs was similar in GP2013-CVP and R-CVP arms (22.8% vs 0%, respectively)
  • Most frequent SAE in GP2013-CVP and R-CVP arms was febrile neutropenia (4.8% vs 9%, respectively)
  • As of 10th July 2015, 35 deaths have been recorded (GP2013-CVP n=18; R-CVP n=17)
  • Most common cause of death in CP2013-CVP and R-CVP arms was Non-Hodgkin Lymphoma (2.6% vs 9%, respectively)
  • Antidrug antibodies developed in 1.9% (n=5) of GP2013-CVP pts and 1.1% (n=3) R-CVP pts

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. 

  1. OncLive®. FDA Accepts Application for Rituximab Biosimilar. 2017 Sep 12. http://www.onclive.com/web-exclusives/fda-accepts-application-for-rituximab-biosimilar. [Accessed 2017 Sep 13].