ASH News Daily 2016 - Issue 2 - A-6
GADOLIN TRIAL1,2:
*
GAZYVA + bendamustine followed by GAZYVA monotherapy was evaluated vs bendamustine alone in a Phase III,
randomized, controlled trial in follicular lymphoma patients who had no response to or who progressed within 6 months
of therapy with a rituximab-containing regimen
*
Patients in the GAZYVA + bendamustine arm who did not have disease progression (patients with a complete response,
partial response, or stable disease) at the end of the 6 cycles continued receiving GAZYVA monotherapy for 2 years
unless disease progression occurred during the treatment
In follicular lymphoma patients who were refractory to a rituximab-containing regimen
GAZYVA + BENDAMUSTINE FOLLOWED BY GAZYVA
MONOTHERAPY PROVIDED SUPERIOR PFS vs BENDAMUSTINE
ALONE1
Primary endpoint: IRC-assessed PFS
52%
Probability of PFS
1.0
0.8
0.6
HR=0.48
95% CI, 0.34-0.68;
P<0.0001; 21.1-month
median follow-up
Median not reached
0.4
GAZYVA + bendamustine
followed by GAZYVA
monotherapy (n=155)
13.8
0.2
0.0
reduction in
the risk of disease
progression or death
0
6
12
Bendamustine (n=166)
18
24
30
36
42
48
1
54
Time (months)
n at risk
GAZYVA + bendamustine
followed by GAZYVA
monotherapy
155
120
79
61
38
20
6
2
Bendamustine
166
122
66
29
17
7
2
1
IRC, independent review committee; HR, hazard ratio; CI, confidence interval.
IMPORTANT SAFETY INFORMATION (CONT'D)
Pregnancy
Additional Important Safety Information
* Of 194 patients with iNHL treated with GAZYVA plus
* The most common adverse reactions (incidence ≥10%) were:
* There are no data with GAZYVA use in pregnant women to
* The safety of GAZYVA was evaluated based on a safety
inform a drug-associated risk. GAZYVA is likely to cause fetal
population of 392 patients with indolent NHL (iNHL), of
B-cell depletion. GAZYVA should be used during pregnancy
whom 81% had follicular lymphoma. In patients with follicular
and/or breastfeeding only if the potential benefit justifies the
lymphoma, the most common adverse reactions that were seen
potential risk to the fetus and/or infant. Mothers who have
were consistent with the overall population who had iNHL
been exposed to GAZYVA during pregnancy should discuss the
Grade 3/4 adverse reactions were: neutropenia (33%), infusion
safety and timing of live virus vaccinations for their infants with *
reactions (11%), thrombocytopenia (10%), urinary tract infection
their child's healthcare providers
(3%), upper respiratory tract infection (2%), pyrexia (1%), asthenia
(1%), sinusitis (1%), and pain in extremity (1%)
Geriatric Use
bendamustine, 44% were 65 and over, while 14% were 75 and
over. In patients 65 and over, 52% of patients experienced
serious adverse events and 26% experienced adverse events
leading to treatment withdrawal while in patients under 65,
28% and 12% experienced serious adverse events and adverse
events leading to treatment withdrawal, respectively. No
clinically meaningful differences in safety and efficacy were
observed between these patients and younger patients
GAZ-082916-0093c_R01_HEMA_GAD_JA_ASH_Daily_News_Ad.indd 4
infusion reactions (69%), neutropenia (35%), nausea (54%),
fatigue (39%), cough (26%), diarrhea (27%), constipation (19%),
pyrexia (18%), thrombocytopenia (15%), vomiting (22%), upper
respiratory tract infection (13%), decreased appetite (18%),
arthralgia (12%), sinusitis (12%), anemia (12%), asthenia (11%), and
urinary tract infection (10%)
* During the monotherapy period with GAZYVA, the most common
Grade 3-4 adverse reactions were neutropenia (10%), and
anemia, febrile neutropenia, thrombocytopenia, sepsis, upper
respiratory tract infection, and urinary tract infection (all at 1%)
Table of Contents for the Digital Edition of ASH News Daily 2016 - Issue 2
ASH News Daily 2016 - Issue 2 - A-1
ASH News Daily 2016 - Issue 2 - A-2
ASH News Daily 2016 - Issue 2 - A-3
ASH News Daily 2016 - Issue 2 - A-4
ASH News Daily 2016 - Issue 2 - A-5
ASH News Daily 2016 - Issue 2 - A-6
ASH News Daily 2016 - Issue 2 - A-7
ASH News Daily 2016 - Issue 2 - A-8
ASH News Daily 2016 - Issue 2 - A-9
ASH News Daily 2016 - Issue 2 - A-10
ASH News Daily 2016 - Issue 2 - A-11
ASH News Daily 2016 - Issue 2 - A-12
ASH News Daily 2016 - Issue 2 - A-13
ASH News Daily 2016 - Issue 2 - A-14
ASH News Daily 2016 - Issue 2 - A-15
ASH News Daily 2016 - Issue 2 - A-16
ASH News Daily 2016 - Issue 2 - A-17
ASH News Daily 2016 - Issue 2 - A-18
ASH News Daily 2016 - Issue 2 - A-19
ASH News Daily 2016 - Issue 2 - A-20
ASH News Daily 2016 - Issue 2 - A-21
ASH News Daily 2016 - Issue 2 - A-22
ASH News Daily 2016 - Issue 2 - A-23
ASH News Daily 2016 - Issue 2 - A-24
ASH News Daily 2016 - Issue 2 - A-25
ASH News Daily 2016 - Issue 2 - A-26
ASH News Daily 2016 - Issue 2 - B-1
ASH News Daily 2016 - Issue 2 - B-2
ASH News Daily 2016 - Issue 2 - B-3
ASH News Daily 2016 - Issue 2 - B-4
ASH News Daily 2016 - Issue 2 - B-5
ASH News Daily 2016 - Issue 2 - B-6
ASH News Daily 2016 - Issue 2 - B-7
ASH News Daily 2016 - Issue 2 - B-8
ASH News Daily 2016 - Issue 2 - B-9
ASH News Daily 2016 - Issue 2 - B-10
ASH News Daily 2016 - Issue 2 - B-11
ASH News Daily 2016 - Issue 2 - B-12
ASH News Daily 2016 - Issue 2 - B-13
ASH News Daily 2016 - Issue 2 - B-14
ASH News Daily 2016 - Issue 2 - B-15
ASH News Daily 2016 - Issue 2 - B-16
ASH News Daily 2016 - Issue 2 - B-17
ASH News Daily 2016 - Issue 2 - B-18
ASH News Daily 2016 - Issue 2 - B-19
ASH News Daily 2016 - Issue 2 - B-20
ASH News Daily 2016 - Issue 2 - B-21
ASH News Daily 2016 - Issue 2 - B-22
ASH News Daily 2016 - Issue 2 - B-23
ASH News Daily 2016 - Issue 2 - B-24
ASH News Daily 2016 - Issue 2 - B-25
ASH News Daily 2016 - Issue 2 - B-26
ASH News Daily 2016 - Issue 2 - B-27
ASH News Daily 2016 - Issue 2 - B-28
ASH News Daily 2016 - Issue 2 - B-29
ASH News Daily 2016 - Issue 2 - B-30
ASH News Daily 2016 - Issue 2 - B-31
ASH News Daily 2016 - Issue 2 - B-32
ASH News Daily 2016 - Issue 2 - B-33
ASH News Daily 2016 - Issue 2 - B-34
ASH News Daily 2016 - Issue 2 - B-35
ASH News Daily 2016 - Issue 2 - B-36
ASH News Daily 2016 - Issue 2 - B-37
ASH News Daily 2016 - Issue 2 - B-38
ASH News Daily 2016 - Issue 2 - B-39
ASH News Daily 2016 - Issue 2 - B-40
ASH News Daily 2016 - Issue 2 - B-41
ASH News Daily 2016 - Issue 2 - B-42
ASH News Daily 2016 - Issue 2 - B-43
ASH News Daily 2016 - Issue 2 - B-44
ASH News Daily 2016 - Issue 2 - B-45
ASH News Daily 2016 - Issue 2 - B-46
ASH News Daily 2016 - Issue 2 - B-47
ASH News Daily 2016 - Issue 2 - B-48
ASH News Daily 2016 - Issue 2 - C-1
ASH News Daily 2016 - Issue 2 - C-2
ASH News Daily 2016 - Issue 2 - C-3
ASH News Daily 2016 - Issue 2 - C-4
ASH News Daily 2016 - Issue 2 - C-5
ASH News Daily 2016 - Issue 2 - C-6
ASH News Daily 2016 - Issue 2 - C-7
ASH News Daily 2016 - Issue 2 - C-8
ASH News Daily 2016 - Issue 2 - C-9
ASH News Daily 2016 - Issue 2 - C-10
ASH News Daily 2016 - Issue 2 - C-11
ASH News Daily 2016 - Issue 2 - C-12
ASH News Daily 2016 - Issue 2 - C-13
ASH News Daily 2016 - Issue 2 - C-14
ASH News Daily 2016 - Issue 2 - C-15
ASH News Daily 2016 - Issue 2 - C-16
ASH News Daily 2016 - Issue 2 - C-17
ASH News Daily 2016 - Issue 2 - C-18
ASH News Daily 2016 - Issue 2 - C-19
ASH News Daily 2016 - Issue 2 - C-20
ASH News Daily 2016 - Issue 2 - C-21
ASH News Daily 2016 - Issue 2 - C-22
ASH News Daily 2016 - Issue 2 - C-23
ASH News Daily 2016 - Issue 2 - C-24
ASH News Daily 2016 - Issue 2 - C-25
ASH News Daily 2016 - Issue 2 - C-26
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