April 2019 digital edition

standard of care.
The phase III multicentre,
randomised, double-blind
PEMPHIX study, evaluating
the efficacy and safety of
rituximab compared with
mycophenolate mofetil (MMF),
an immunosuppressant, in
patients with moderate to
severe PV, is ongoing.
PV is the most common
type of a group of autoimmune
disorders collectively called
pemphigus.
EC clears
pembrolizumab
combo for
mNSCLC
P
embrolizumab (Keytruda),
an anti-PD-1 therapy, in
combination with carboplatin
and either paclitaxel or
nab-paclitaxel, has been
approved by EC for the firstline
treatment of adults with
metastatic squamous nonsmall
cell lung cancer (NSCLC),
Merck announced.
This approval is based
on data from the phase
3 KEYNOTE-407 trial,
which demonstrated that
pembrolizumab in combination
with chemotherapy significantly
improved overall survival
(OS) in adults with metastatic
squamous NSCLC regardless
of PD-L1 tumour expression
status, reducing the risk of
death by 36 percent compared
to chemotherapy alone.
In NSCLC, pembrolizumab
is also approved in Europe
for the first-line treatment
Once-daily eye drop for
glaucoma
The US FDA has okayed
new drug netarsudil
0.02% and latanoprost
0.005% ophthalmic
solution (Rocklatan) for
the reduction of elevated
intraocular pressure (IOP)
in patients with openangle
glaucoma or ocular
hypertension.
The once-daily eye
drop that is a fixed-dose
combination of latanoprost,
the most widely-prescribed
prostaglandin analogue
(PGA), and netarsudil,
the active ingredient in
netarsudil ophthalmic
solution 0.02%, a first-inclass
Rho kinase (ROCK)
inhibitor specifically
designed to target the
trabecular meshwork.
The diseased trabecular
of metastatic nonsquamous
NSCLC in combination with
pemetrexed and platinum
chemotherapy in adults whose
tumours have no EGFR or ALK
positive mutations.
Pembrolizumab in
combination with carboplatin
and either paclitaxel or nabpaclitaxel
significantly improved
meshwork is considered
to be the main cause of
elevated IOP in openangle
glaucoma and ocular
hypertension.
Aerie, the maker of
the drug, plans to launch
the drug in the US in the
second quarter of 019.
The FDA approval of
is based on data from
two phase 3 registration
trials, MERCURY 1 and
MERCURY 2. In these
studies, the drug achieved
its primary 90-day
efficacy endpoint as well
as positive 12-month
safety and efficacy results,
demonstrating statistically
superior IOP reduction over
latanoprost and netarsudil
at every measured time
point.
OS, reducing the risk of death
by 36 percent compared to
chemotherapy alone.
Pembrolizumab is an anti-
PD-1 therapy that works by
increasing the ability of the
body’s immune system to help
detect and fight tumour cells.
The humanized monoclonal
antibody blocks the interaction
between PD-1 and its ligands,
PD-L1 and PD-L2, thereby
activating T lymphocytes which
may affect both tumour cells
and healthy cells.
Emicizumab for
haemophilia A
without FVIII
in EC
Roche said EC cleared
emicizumab (Hemlibra) for
routine prophylaxis of bleeding
episodes in people with severe
haemophilia A without factor
VIII inhibitors from EC.
Emicizumab can be used
in all age groups and can also
now be used at multiple dosing
options for all indicated people
with haemophilia A, including
those with factor VIII inhibitors.
This approval is based
on results from the pivotal
HAVEN 3 and HAVEN 4 studies.
In the HAVEN 3 study in
people with haemophilia A
without factor VIII inhibitors,
emicizumab prophylaxis led
to statistically significant and
clinically meaningful reductions
in treated bleeds compared to
no prophylaxis and compared
to prior treatment with factor
VIII prophylaxis in a prospective
intra-patient comparison.
In the HAVEN 4 study in
people with haemophilia A
with and without factor VIII
inhibitors, emicizumab showed
a clinically meaningful control
April 2019 / FUTURE MEDICINE / 41