CLINICAL NEWS
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DEA Revises
Registration Renewal
Process … Twice
In November 2016, the U.S. Department
of Justice’s Drug Enforcement Administra-
tion (DEA) announced significant changes
to its registration renewal process effective
January 1, 2017. The DEA said it would
send one renewal notice to each regis-
trant’s mailing address approximately 65
days prior to the expiration date; no other
reminders would be provided. The revised
rule also suspended online capabilities to
renew a DEA registration after the expira-
tion date – putting an end to the informal
grace period for registration renewal.
Failure to file for renewal before midnight
Eastern Standard Time on the expiration
date would result in the “retirement” of the
registrant’s DEA number, which could not
be reinstated with a subsequent filing (a
new number would have to be provided).
After a number of organizations,
including the American Medical
Association, urged the DEA to reverse its
decision because of the problems it could
create for both physicians and patients,
the DEA moved to revise the renewal
process, allowing for reinstatement of an
expired registration for a month after the
expiration date, after which a new DEA
application will be required. The DEA
also said it will issue a second renewal
notification via email following the initial
mailed renewal notice.
For more information, visit
deadiversion.usdoj.gov/drugreg.
Source: U.S. Department of Justice Diversion Control Division website.
The DEA
reversed the
changes to its
registration
renewal process
over concerns
about the
problems it
could create for
physicians and
patients.
ASHClinicalNews.org
FDA Lifts Clinical
Hold on Pacritinib
for the Treatment of
Myelofibrosis
The U.S. Food and Drug Administration
(FDA) has lifted the full clinical hold
placed on all clinical trials of pacritinib –
an oral kinase JAK2/FLT3 inhibitor – for
treatment for myelofibrosis (MF).
The FDA placed the hold on
pacritinib in February 2016 after
two phase III trials (PERSIST-1 and
PERSIST-2) resulted in deaths related to
intracranial hemorrhage, cardiac failure,
and cardiac arrest. The FDA suggested
that the drug’s manufacturer (CTI
BioPharma) conduct dose-exploration
studies, submit final study reports and
data sets for PERSIST-1 and PERSIST-2,
make certain modifications to protocols
and study-related documents, and
request a meeting with the FDA prior to
submitting a response to the full clinical
hold.
As a result, CTI BioPharma is
planning the PAC203 trial, which will
evaluate the safety and dose-response
relationship for efficacy (defined as
spleen volume reduction at 24 weeks) of
pacritinib at three doses: 100 mg once
daily, 100 mg twice daily, and 200 mg
twice daily (this was the dose used in
PERSIST-2). Investigators plan to enroll
approximately 105 patients with primary
MF who have failed prior ruxolitinib
therapy.
Source: CTI BioPharma news release, January 6, 2017.
FDA Grants
Breakthrough
Designation for
JCAR017 for the
Treatment of Non-
Hodgkin Lymphoma
The FDA granted breakthrough therapy
designation for JCAR017 – a CD19-
targeted chimeric antigen receptor (CAR)
T-cell therapy – for patients with relapsed/
refractory, aggressive large B-cell non-
Hodgkin lymphoma (NHL), specifically
those with diffuse large B-cell lymphoma
(DLBCL), primary mediastinal B-cell
lymphoma, grade 3B follicular lymphoma
(FL), or disease not otherwise specified
Mucosa-associated lymphoid tissue (MALT)
(de novo or transformed from indo