RITUXAN HYCELA CLINICAL DEVELOPMENT PROGRAM:
4 QUESTIONS, 4 TRIALS, OVER 1,900 PATIENTS STUDIED 1,2

CLINICAL DEVELOPMENT PROGRAM OUTCOMES 1

1. Based on a PK-bridging approach, RITUXAN HYCELA achieved rituximab Ctrough non-inferiority with a fixed dose and the same dosing intervals vs RITUXAN:

  • Previously Untreated FL (SABRINA Trial):
    • 1,400 mg rituximab and 23,400 Units hyaluronidase human
    • Delivered as a fixed dose in an 11.7 mL single-dose vial
  • Previously Untreated CLL (SAWYER Trial):
    • 1,600 mg rituximab and 26,800 Units hyaluronidase human
    • Delivered as a fixed dose in a 13.4 mL single-dose vial

2. The incidence and profile of adverse reactions reported for RITUXAN HYCELA were comparable with those for RITUXAN, with the exception of local cutaneous reactions, based on:

  • Previously untreated FL (SABRINA Trial)
  • Previously untreated DLBCL (MabEASE Trial)
  • Previously untreated CLL (SAWYER Trial)

3. The RITUXAN HYCELA efficacy results were comparable to RITUXAN based on:

  • Previously untreated FL (SABRINA Trial)
  • Previously untreated DLBCL (MabEASE Trial)
  • Previously untreated CLL (SAWYER Trial)

The overall response rates were comparable between RITUXAN HYCELA and RITUXAN.

4. Most patients demonstrated an administration preference for RITUXAN HYCELA vs RITUXAN based on:

  • Previously untreated FL and DLBCL (PrefMab Trial)
Learn more about the SABRINA Trial
Learn more about the MabEASE Trial
Learn more about the SAWYER Trial
Learn more about the PrefMab Trial