ASH Clinical News February 2016 | Page 26

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In May 2015, the FDA issued a formal
proposal recommending ending the ban;
the recent action marks the official acceptance of this proposal.
“In reviewing our policies to help
reduce the risk of HIV transmission
through blood products, we rigorously
examined several alternative options,
including individual risk assessment,” said
Peter Marks, MD, PhD, deputy director
of the Center for Biologics Evaluation and

Research at the U.S. FDA. “Ultimately, the
12-month deferral window is supported
by the best available scientific evidence,
at this point in time, relevant to the U.S.
population. We will continue to actively
conduct research in this area and further
revise our policies as new data emerge.”
Critics, including the lesbian-gaybisexual-transgender (LGBT) community, object to the 12-month deferral
requirement, arguing that current

blood donation testing detects all
known serious bloodborne pathogens,
including HIV, within 45 days of exposure. A shorter deferral window of two
months or less would be suitable, the
LGBT community argues. Other countries, including the United Kingdom
and Australia, have 12-month deferrals
for blood donations from MSM.
The FDA issued additional guidance
recommending that blood centers make

Table 5: Most Frequently Reported Non-hematologic Adverse Reactions
(Regardless of Relationship to Study Drug) in Patients with Newly
Diagnosed Ph+ CML-CP (≥10% in Tasigna 300 mg Twice-Daily or
Imatinib 400 mg Once-Daily Groups) 60-Month Analysisa
Patients with Newly Diagnosed
Ph+ CML-CP
TASIGNA Imatinib TASIGNA Imatinib
300 mg 400 mg 300 mg 400 mg
twiceoncetwiceoncedaily
daily
daily
daily
N=279 N=280 N=279 N=280
All Grades (%)
CTC Gradesb
Body System and Preferred Term
3/4 (%)
Skin and
Rash
38
19
<1
2
subcutaneous
Pruritus
21
7
<1
0
tissue disorders Alopecia
13
7
0
0
Dry skin
12
6
0
0
Gastrointestinal
Nausea
22
41
2
2
disorders
Constipation
20
8
<1
0
Diarrhea
19
46
1
4
Vomiting
15
27
<1
<1
Abdominal pain
upper
18
14
1
<1
Abdominal pain
15
12
2
0
Dyspepsia
10
12
0
0
Nervous system Headache
32
23
3
<1
disorders
Dizziness
12
11
<1
<1
General disorders Fatigue
23
20
1
1
and administration Pyrexia
14
13
<1
0
site conditions
Asthenia
14
12
<1
0
Peripheral edema
9
20
<1
0
Face edema
<1
14
0
<1
Musculoskeletal Myalgia
19
19
<1
<1
and connective
Arthralgia
22
17
<1
<1
tissue disorders Muscle spasms
12
34
0
1
Pain in extremity
15
16
<1
<1
Back pain
19
17
1
1
Respiratory,
Cough
17
13
0
0
thoracic and
Oropharyngeal
mediastinal
pain
12
6
0
0
disorders
Dyspnea
11
6
2
<1
Infections and
Nasopharyngitis
27
21
0
0
infestations
Upper respiratory
tract infection
17
14
<1
0
Influenza
13
9
0
0
Gastroenteritis
7
10
0
<1
Eye disorders
Eyelid edema
1
19
0
<1
Periorbital edema
<1
15
0
0
Psychiatric
Insomnia
11
9
0
0
disorders
Vascular disorder Hypertension
10
4
1
<1
a Excluding laboratory abnormalities
b NCI Common Terminology Criteria for Adverse Events, Version 3.0
Table 6: Most Frequently Reported Non-hematologic Adverse Reactions in
Patients with Resistant or Intolerant Ph+ CML Receiving Tasigna
400 mg Twice-Daily (Regardless of Relationship to Study Drug)
(≥10% in any Group) 24-Month Analysisa
CML-CP
CML-AP
N=321
N=137
All
CTC
All
CTC
Grades Gradesb Grades Gradesb
Body System and Preferred Term
(%)
3/4 (%)
(%)
3/4 (%)
Skin and
Rash
36
2
29
0
subcutaneous
Pruritus
32
<1
20
0
tissue disorders Night sweat
12
<1
27
0
Alopecia
11
0
12
0
Gastrointestinal
Nausea
37
1
22
<1
disorders
Constipation
26
<1
19
0
Diarrhea
28
3
24
2
Vomiting
29
<1
13
0
Abdominal pain
15
2
16
3
Abdominal pain
upper
14
<1
12
<1
Dyspepsia
10
<1
4
0
(continued)

79892ha_t.indd 6

corresponding revisions to donor educational materials, donor history questionnaires, and accompanying materials, as
well as donor requalification and product
management procedures.
Sources: U.S. FDA news release, December 21, 2015; U.S. FDA, “Revised
recommendations for reducing the risk of human immunodeficiency
virus transmission by blood and blood products – questions and
answers.”

Table 6: Most Frequently Reported Non-hematologic Adverse Reactions in
Patients with Resistant or Intolerant Ph+ CML Receiving Tasigna
400 mg Twice-Daily (Regardless of Relationship to Study Drug)
(≥10% in any Group) 24-Month Analysisa
CML-CP
CML-AP
N=321
N=137
All
CTC
All
CTC
Grades Gradesb Grades Gradesb
Body System and Preferred Term
(%)
3/4 (%)
(%)
3/4 (%)
Nervous system Headache
35
2
20
1
disorders
General disorders Fatigue
32
3
23
<1
and administration Pyrexia
22
<1
28
2
site conditions
Asthenia
16
0
14
1
Peripheral edema
15
<1
12
0
Musculoskeletal Myalgia
19
2
16
<1
and connective
Arthralgia
26
2
16
0
tissue disorders Muscle spasms
13
<1
15
0
Bone pain
14
<1
15
2
Pain in extremity
20
2
18
1
Back pain
17
2
15
<1
Musculoskeletal
pain
11
<1
12
1
Respiratory,
Cough
27
<1
18
0
thoracic and
Dyspnea
15
2
9
2
mediastinal
Oropharyngeal
disorders
pain
11
0
7
0
Infections and
Nasopharyngitis
24
<1
15
0
infestations
Upper respiratory
tract infection
12
0
10
0
Metabolism and Decreased
nutrition
appetitec
15
<1
17
<1
disorders
Psychiatric
Insomnia
12
1
7
0
disorders
Vascular disorders Hypertension
10
2
11
<1
a Excluding laboratory abnormalities
b NCI Common Terminology Criteria for Adverse Events, Version 3.0
c Also includes preferred term anorexia
Laboratory Abnormalities
Table 7 shows the percentage of patients experiencing treatment-emergent
Grade 3/4 laboratory abnormalities in patients who received at least one
dose of Tasigna.
Table 7: Percent Incidence of Clinically Relevant Grade 3/4* Laboratory
Abnormalities
Patient Population
Resistant or
Intolerant Ph+
Newly Diagnosed
Ph+ CML-CP
CML-CP
CML-AP
TASIGNA Imatinib
TASIGNA TASIGNA
300 mg
400 mg
400 mg
400 mg
twice-daily once-daily twice-daily twice-daily
N=279
N=280
N=321
N=137
(%)
(%)
(%)
(%)
Hematologic Parameters
Thrombocytopenia
10
9
301
423
Neutropenia
12
22
312
424
Anemia
4
6
11
27
Biochemistry Parameters
Elevated lipase
9
4
18
18
Hyperglycemia
7
<1
12
6
Hypophosphatemia
8
10
17
15
Elevated bilirubin (total)
4
<1
7
9
Elevated SGPT (ALT)
4
3
4
4
Hyperkalemia
2
1
6
4
Hyponatremia
1
<1
7
7
Hypokalemia
<1
2
2
9
Elevated SGOT (AST)
1
1
3
2
Decreased albumin
0
<1
4
3
Hypocalcemia
<1
<1
2
5
Elevated alkaline
phosphatase
0
<1
<1
1
(continued)

9/11/15 10:00 PM