FIRST
AND ONLY
GAZYVA Is the First and Only Approved Therapy That
Demonstrated Superior PFS vs rituximab in Previously
Untreated FL 1
With chemotherapy * for stage II bulky, III, and IV patients
Primary Endpoint: PFS (IRC-assessed) 1
1.0
28 % %
0.8
reduction in the risk
of disease progression
or death
0.6
Medians not yet reached
HR=0.72
95% CI, 0.56-0.93;
P=0.0118;
38-month median
observation time
0.4
0.2
0.0
0
6 12 18 24 GAZYVA based
regimen 601 571 532 497 476 414 287
rituximab-based
regimen 601 563 502 463 438 394 271
n at risk
*
30
36
42
Time (months)
48 54
179 79 22
151 73 16
60
66
GAZYVA and rituximab were each combined with bendamustine, CHOP, or CVP, and followed by GAZYVA or rituximab monotherapy, respectively, in
patients who responded.
• 1,202 untreated FL patients studied (Grades 1-3a, stage III/IV or stage II bulky disease [≥7 cm])
• Patients randomized to receive GAZYVA a or rituximab b in combination with chemotherapy for 6 or 8 cycles, followed
by either GAZYVA or rituximab monotherapy every 2 months for up to 2 years c
• GAZYVA and rituximab were combined with bendamustine (57% of patients), CHOP (33%), or CVP (10%) †
Each dose of GAZYVA was 1,000 mg IV on Days 1, 8, and 15 of Cycle 1, and 1,000 mg on Day 1 of subsequent treatment cycles. 1
Each dose of rituximab was 375 mg/m 2 IV administered on Day 1 of each cycle. 2
c
In patients achieving a CR or PR at the end of 6-8 cycles, GAZYVA or rituximab monotherapy was administered every 2 months until disease progression
or for a maximum of 2 years. 1
†
Treatment arms were generally balanced with respect to demographic factors and baseline disease characteristics. 2
a
b
Important Safety Information (cont’d)
Immunization Geriatric Use
• The safety and effi cacy of immunization with live or
attenuated viral vaccines during or following GAZYVA
therapy have not been studied. Immunization with live
virus vaccines is not recommended during treatment
and until B-cell recovery
Pregnancy
• There are no data with GAZYVA use in pregnant women
to inform a drug-associated risk. GAZYVA is likely to
cause fetal B-cell depletion. GAZYVA should be used
during pregnancy and/or breastfeeding only if the
potential benefi t justifi es the potential risk to the fetus
and/or infant. Mothers who have been exposed to
GAZYVA during pregnancy should discuss the safety
and timing of live virus vaccinations for their infants with
their child’s healthcare providers • Of the 691 patients in GALLIUM treated with GAZYVA
plus chemotherapy as fi rst-line therapy, 33% were 65
and over, while 7% were 75 and over. Of patients 65 and
over, 63% experienced serious adverse reactions and
26% experienced adverse reactions leading to treatment
withdrawal, while in patients under 65, 43% experienced
serious adverse reactions and 13% had an adverse
reaction leading to treatment withdrawal. No clinically
meaningful diff erences in effi cacy were observed
between these patients and younger patients
Please see additional Important Safety Information throughout as well as the brief summary
of the full Prescribing Information, including BOXED WARNINGS.