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


  • 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

Warnings and Precautions: Infections

  • Fatal and serious bacterial, fungal, and new or reactivated viral infections can occur during and following GAZYVA therapy. When GAZYVA is administered with chemotherapy followed by GAZYVA monotherapy, Grade 3 to 5 infections have been reported in up to 8% of patients during combination therapy, up to 13% of patients during monotherapy, and up to 8% of patients after treatment. Do not administer GAZYVA to patients with an active infection. Patients with a history of recurring or chronic infections may be at increased risk of infection
  • In GALLIUM, more Grade 3 to 5 infections were reported in the recipients of GAZYVA and bendamustine (117/410 patients, 29%), as compared to GAZYVA plus CHOP or CVP (43/281 patients, 15%). More fatal infections were reported in patients treated with GAZYVA and bendamustine (3%), as compared to GAZYVA plus CHOP or CVP (<1%), including during the monotherapy phase and after completion of treatment