GAZYVA Is the First and Only Approved Therapy That
Demonstrated Superior PFS vs rituximab in Previously
Untreated FL 1
FIRST
AND ONLY
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%) †
a
Each dose of GAZYVA was 1,000 mg on Days 1, 8, and 15 of Cycle 1, and 1,000 mg on Day 1 of subsequent treatment cycles. 1
b Each dose of rituximab was 375 mg/m 2 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
Important Safety Information (cont’d)
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
Geriatric Use
•
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.