ASH Clinical News ACN_4.10_FULL ISSUE web | Page 24

Latest & Greatest
Venetoclax Approved
for All Patients With
CLL and SLL
The U.S. Food and Drug Administration
(FDA) granted approval to venetoclax
for the treatment of patients with pre-
viously treated chronic lymphocytic
leukemia (CLL) or small lymphocytic
lymphoma (SLL), regardless of del17p
status. The BCL2 inhibitor was previ-
ously approved in April 2016 for the
treatment of patients with previously
treated CLL/SLL who also harbored a
del17p mutation.
The agency’s decision was based
on data from the phase III MURANO
randomized trial that compared veneto-
clax with bendamustine, in combination
with rituximab, in 389 patients. In the
venetoclax group, the response rate was
92 percent, compared with 72 percent
for those treated with bendamustine. At
a median follow-up of 23 months (range
not reported), progression-free sur-
vival was not reached in the venetoclax
group, compared with 18.1 months in
the bendamustine group (hazard ratio =
0.19; 95% CI 0.13-0.28; p<0.0001).
In patients receiving the venetoclax
combination, the most common adverse
events (AEs) included neutropenia, diar-
rhea, upper respiratory–tract infection,
fatigue, cough, and nausea. Serious AEs
occurred in 46 percent of patients, and
21 percent of patients developed serious
infections. The investigators also noted
that rapid reduction in tumor volume
makes tumor lysis syndrome an impor-
tant risk to consider.
Source: FDA press release, June 8, 2018.
FDA Approves
Pembrolizumab for
Relapsed/Refractory
PMBCL
Pembrolizumab was granted an ac-
celerated approval by the FDA for the
treatment of adult and pediatric patients
with refractory primary mediastinal
large B-cell lymphoma (PMBCL), or
patients whose disease relapsed after
receiving two or more prior lines of
therapy.
The agency based its decision on
results from the multicenter, open-label,
single-arm KEYNOTE-170 trial, which
enrolled 53 patients with relapsed/
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ASH Clinical News
refractory PMBCL who received pem-
brolizumab 200 mg intravenously every
three weeks until unacceptable toxicity or
documented disease progression.
After a median follow-up of 9.7
months (range not reported), the overall
response rate was 45 percent, including
a complete response rate of 11 percent
and a partial response rate of 34 percent.
The median time to response was 2.8
months (range = 2.1-8.5 months), and
the median duration of response was not
reached (range = 1.1 to >19.2 months)
within the follow-up period.
The most common AEs (occurring in
≥10% of patients) included musculoskel-
etal pain (30%), upper respiratory–tract
infection (28%), pyrexia (28%), fatigue
(23%), cough (26%), dyspnea (21%),
diarrhea (13%), abdominal pain (13%),
nausea (11%), arrhythmia (11%), and
headache (11%). Grade 3/4 AEs included
dyspnea (11%), arrhythmia (4%), fatigue
(2%), cough (2%), and diarrhea (2%).
The approval letter noted that pem-
brolizumab is not recommended for
treatment of patients with PMBCL who
require urgent cytoreductive therapy, and
the accelerated approval for pembroli-
zumab in this setting is contingent on the
results of a confirmatory trial.
eliminate any barriers that stand in the
way of physicians accessing needed men-
tal health-care services.”
As a part of these efforts, the AMA
is encouraging state medical licensure
boards to ask physicians only about
current mental or physical disabilities
that could affect the provider’s ability to
practice medicine in a competent, ethi-
cal, and professional manner. The recom-
mendation would reduce the most severe
consequences for reporting or seeking
treatment, such as dismissal or suspen-
sion of medical license.
“We must do
everything
we can to ...
eliminate any
barriers that
stand in the way
of physicians
accessing
needed mental
AMA Announces New health-care
Approach to Physician services.”
Mental Health Care
—DAVID O. BARBE, MD
Source: FDA news release, June 13, 2018.
In response to growing concerns about
the mental health of physicians and
medical students, the America