FM DECEMBER 2018 ISSUE - digital edition

selective FLT3 inhibitor
currently in phase 3
development.
The EU approval was
based on results of the pivotal
phase 3 QuANTUM-R study of
quizartinib, which was the first
randomized phase 3 study to
show that an FLT3 inhibitor
prolonged overall survival
as an oral, single agent
compared to chemotherapy
in patients with relapsed/
refractory FLT3-ITD AML.
The median treatment
duration with quizartinib was
4 cycles of 28 days each
versus 1 cycle in the salvage
chemotherapy arm.
Quizartinib is currently
under regulatory review
with the Japan Ministry of
Health, Labour and Welfare
(MHLW) for the treatment of
adult patients with relapsed/
refractory FLT3-ITD AML.
Submission in the US remains
on track for the second half of
the fiscal year 2018.
Lorlatinib for
ALK-positive
NSCLC
Lorlatinib (Lorbrena) has
been granted US FDA
approval to treat patients with
ALK-positive metastatic nonsmall
cell lung cancer (NSCLC),
Pfizer Inc announced.
Lorlatinib, a thirdgeneration
anaplastic
lymphoma kinase (ALK)
tyrosine kinase inhibitor
(TKI), is indicated for patients
whose disease has progressed
on crizotinib and at least
one other ALK inhibitor for
metastatic disease; or whose
disease has progressed on
alectinib or ceritinib as the
first ALK inhibitor therapy for
metastatic disease.
This indication is approved
under accelerated approval
based on tumour response
rate and duration of response.
The approval was based
on a non-randomized,
dose-ranging and activityestimating,
multi-cohort,
multicentre phase 1/2 study,
B7461001, evaluating Lorbrena
CHMP gives positive
opinion for dengue vac
The European Medicines
Agency’s Committee
for Medicinal Products
for Human Use (CHMP)
recommended Dengvaxia,
Sanofi’s dengue vaccine
candidate, for approval in
Europe.
The indication for
the dengue vaccine
recommended by the CHMP
is for use in the prevention
of dengue disease caused
by dengue virus serotypes
1, 2, 3 and 4 in individuals
9 to 45 years of age with
prior dengue virus infection
and living in endemic areas.
European Commission
approval of the vaccine
is expected in December
2018.
A person can get
dengue more than once
as there are four distinct
virus serotypes circulating
worldwide. Dengue
infection is unique in that
a secondary infection
tends to be worse than the
first infection. Therefore,
preventing dengue in
individuals with a prior
dengue infection has the
potential to reduce the high
human and economic costs
of severe dengue.
The dengue vaccine has
been evaluated in studies
involving more than 40,000
people from 15 countries
with up to six years of
follow-up data from largescale
clinical safety and
efficacy investigations.
The vaccine is currently
licensed in 20 countries for
the prevention of dengue.
for the treatment of patients
with ALK-positive metastatic
NSCLC, who were previously
treated with one or more ALK
TKIs. A total of 215 patients
with ALK-positive metastatic
NSCLC were enrolled across
various subgroups based on
prior treatment. Among these
patients, overall response rate
(ORR) was 48 percent and
importantly, 57 percent had
previous treatment with more
than one ALK TKI.
Combo drug for
brochodilation
in EU
The European Commission
has authorised an
expanded label for oncedaily
fluticasone furoate/
umeclidinium/vilanterol ‘FF/
UMEC/VI’ (Trelegy Ellipta) for
patients with moderate to
severe chronic obstructive
pulmonary disease (COPD)
not adequately treated with
dual bronchodilation or with
an inhaled corticosteroid (ICS)
and a long-acting ß2-agonist
(LABA).
Bronchodilation is
recognised as the foundation
of COPD therapy. However,
many patients may continue
to struggle with symptoms
and exacerbations over time.
The expanded indication
for the triple-drug regimen
reflects the evidence
supporting its potential
benefits in a broader group
of patients than originally
indicated, giving them the
option of taking a once-daily
36 / FUTURE MEDICINE / DECEMBER 2018