The GAZYVA Based Regimen* Is the First and Only Approved Therapy That Demonstrated Superior PFS vs the rituximab-based Regimen* in Previously Untreated FL 1

For stage II bulky, III, and IV patients

Select Important Safety Information

BOXED WARNINGS: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

  • Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation
  • Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA

Fewer Patients Progressed or Died With the GAZYVA Based Regimen vs the rituximab-based Regimen 1

With a median observation time of 38 months

GALLIUM Studied PFS Overall and by Chemotherapy Subgroup in the Primary and Exploratory Analyses

In the primary PFS analysis, the GAZYVA based regimen delivered superior PFS vs the rituximab-based regimen as assessed by IRC, reducing patients’ risk of disease progression or death by 28% (38-month median observation time; HR=0.72; 95% CI, 0.56-0.93; P=0.0118; median PFS was not reached in either arm) 1