Ruxience® Data

RUXIENCE® has efficacy and safety profiles similar to those of reference rituximab®2

RUXIENCE® demonstrated equivalent efficacy vs reference rituximab2

In patients with LTB-FL, RUXIENCE® and Reference Rituximab had comparable ORRs2

rux_orr_graph

Study design

• The 95% CI fell entirely within the equivalence margin2

ORRs from the 52-week analysis are consistent with these results5

LTB-FL=low-tumor burden follicular lymphoma. ORR=objective response rate.

RUXIENCE® has a safety profile similar to that of reference rituximab3

Adverse events of all causality and related to study drug occurring in >2% of patients3

rux_adverse_events

• The majority of all subjects experienced at least 1 treatment-emergent adverse event (TEAE), regardless of causality, during the study3

– RUXIENCE® group: 154 subjects (78.6%); Reference Rituximab group: 142 subjects (72.1%)

• The proportion of subjects with Grade 3 treatment-related events was comparable between the 2 treatment groups: 4.6% and 3.6% for RUXIENCE® and Reference Rituximab, respectively3

• In both the RUXIENCE® and Reference Rituximab groups, 1.0% of subjects reported serious adverse events related to study drug3

 

 

REFERENCES

  1. RUXIENCE® Summary of Product Characteristics.
  2. Data on file. Rituximab clinical overview. Pfizer Inc.
  3. Yin D, Becker J-C, Melia LA. A Phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritis with active disease in TNF failures (REFLECTIONS B328-01). Poster FRI0309 presented at: European League Against Rheumatism (EULAR) 2014 Annual Congress; June 11-14, 2014; Paris, France. 
  4. Ryan AM, Sokolowski SA, Ng C-K, et al. Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera®). Toxicol Pathol. 2014;42(7):1069-1081. 
  5. Karnik S, Thompson MS, DeGruttola H, et al. Characterization and comparison of PF-05280586, a proposed rituximab biosimilar, to the licensed product. Poster M1038 presented at: American Association of Pharmaceutical Scientists-National Biotech Conference; May 20-22, 2013; San Diego, CA. 
  6. Data on file. Pfizer oncology strategy and pipeline. Pfizer Inc.
  7. RETACRIT® Summary of Product Characteristics.
  8. TRAZIMERA® Summary of Product Characteristics.
  9. NIVESTIM® Summary of Product Characteristics.
  10.  ZIRABEV® Summary of Product Characteristics.

 

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SPC for how to report adverse reactions.

Legal Category: POM S1A

PP-RIT-IRL-0038. Preparation Date: April 2022