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

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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

PFS Was Studied Across Age Subgroups in an Exploratory Analysis 6

  • The median age of patients in the GALLIUM Trial was 59 years (range 23-88)
  • IRC-assessed PFS by age subgroup was an exploratory analysis and was not powered to demonstrate statistically significant differences between treatment arms

Disease Progression at 24 Months With the GAZYVA Based Regimen vs the rituximab-based Regimen in the GALLIUM Study