March 2019 digital v1

treatment of people with
relapsed or refractory (R/R)
diffuse large B-cell lymphoma
(DLBCL).
The GO29365, a global,
phase Ib/II randomized study,
showed that polatuzumab
vedotin plus BR improved
median overall survival
compared to BR alone in
people with R/R DLBCL not
eligible for a hematopoietic
stem cell transplant. The
study also showed that 40
percent of people treated with
polatuzumab vedotin plus BR
achieved a complete response
(CR), while only 18 percent of
people treated with BR alone
achieved a CR.
Polatuzumab is developed
by Genentech, a member of
the Roche Group.
Renexus to treat
macular disease
The US FDA has granted
Fast Track designation
for NT-501 or Renexus for
the treatment of macular
telangiectasia type 2
(MacTel), Neurotech
Pharmaceuticals said.
Renexus is a novel
cell-based drug delivery
system. Human-derived
cells encapsulated in a
semipermeable hollow fibre
membrane device release
US FDA panel okays esketamine
nasal spray for depression
The Janssen
Pharmaceutical
Companies of Johnson
& Johnson announced
that the US Food and
Drug Administration (FDA)
recommended the use
of esketamine (Spravato)
for treatment resistant
depression.
The
psychopharmacologic
drug advisory committee
and drug safety and risk
management advisory
committee of US FDA jointly
voted that data support
the favorable benefit-risk
profile of esketamine nasal
spray CIII for adults living
with treatment-resistant
depression.
Esketamine is thought
to work differently than
currently approved therapies
for major depressive
disorder (MDD). If approved,
esketamine would provide
the first new mechanism of
action in 30 years to treat
this debilitating mental
illness.
ciliary neurotrophic factor
(CNTF) demonstrated to
reduce photoreceptor cell loss
in animal models of retinal
degeneration.
The implanted Renexus
device results in sustained
The committees based
their support on the safety
and efficacy data from five
phase 3 studies in patients
with treatment-resistant
depression: three short-term
studies; one maintenance
of effect study; and one
long-term safety study. In
addition, the esketamine
research programme
provided supportive data
from three Phase 2 studies
and 19 phase 1 studies in
patients with treatmentresistant
depression and
healthy volunteers.
Esketamine is a
glutamate receptor
modulator, thought to help
restore synaptic connections
in brain cells in people
with the major depressive
disorder.
The US FDA has granted
Breakthrough Therapy
Designations for esketaine
for treatment-resistant
depression and for a second
indication, major depressive
disorder with imminent risk
for suicide.
delivery of CNTF localized to
the retina, the light-sensing
tissue in the back of the
eye. MacTel is a rare macular
degenerative disease typically
diagnosed in middle age.
Patients rarely experience total
vision loss, but the disease
nonetheless has a significant
impact, through visual loss, on
a patient’s quality of life.
Based on the positive
phase 2 results, two parallel
phase 3 studies were initiated.
Macular telangiectasia
(MacTel), or idiopathic
juxtafoveal macular
telangiectasia, is a rare
neurodegenerative disease
with characteristic alterations
of the retinal vasculature and
localized retinal degeneration.
Triclabendazole
to treat
fascioliasis
N
ovartis said triclabendazole
(Egaten) has won approval
from the US FDA for the
treatment of fascioliasis in
patients six years of age and
older.
Triclabendazole is
currently the only medicine
for fascioliasis recommended
by the WHO and is on the
WHO Model List of Essential
Medicines.
Fascioliasis, commonly
known as liver fluke infestation,
is a neglected tropical disease
that infects 2.4 million people
worldwide, with an additional
180 million at risk of infection.
It is caused by two species
March 2019 / FUTURE MEDICINE / 33