may edition file

under the Priority Review
programme.
Romosozumab
to treat
osteoporosis
Amgen and UCB
announced that the
US FDA has approved
romosozumab-aqqg
(Evenity) for the treatment
of osteoporosis in
postmenopausal women at
high risk for fracture.
Romosozumab-aqqg
has a dual effect that both
increases bone formation and
to a lesser extent reduces
bone resorption. A full course
of the therapy is 12 monthly
doses.
The FDA based its
approval of romosozumabaqqg
on the results of two
phase 3 studies. In the
placebo-controlled FRAME
study, treatment with
dacomitinib (Vizimpro), a
tyrosine kinase inhibitor
(TKI), as monotherapy for
the first-line treatment
of adult patients with
locally advanced or
metastatic non-small cell
lung cancer (NSCLC) with
epidermal growth factor
receptor (EGFR)-activating
mutations.
The EC approval of
dacomitinib was supported
by data from ARCHER 1050,
a randomized, multicentre,
multinational, open-label,
phase 3 study conducted in
patients with unresectable,
metastatic or recurrent
NSCLC, harbouring EGFR
exon 19 deletion or exon 21
L858R substitution
mutations.
Dacomitinib is also
approved in the US for the
first-line treatment of patients
with metastatic NSCLC with
EGFR exon 19 deletion or
exon 21 L858R substitution
mutations as detected
by an FDA-approved test.
Additionally, it is approved
in Japan for EGFR gene
mutation-positive, inoperable
or recurrent NSCLC, and
in Canada for the first-line
treatment of adult patients
with unresectable locally
advanced or metastatic
NSCLC with confirmed
EGFR exon 19 deletion or
exon 21 L858R substitution
mutations. The applications
in the US and Japan were
reviewed and approved
Cladribine as oral treatment for
multiple sclerosis
Cladribine (Mavenclad) has been granted approval
to treat relapsing forms of multiple sclerosis (MS) in
adults by the USFDA.
Cladribine is not recommended for MS patients
with clinically isolated syndrome. Because of its safety
profile, the use of the drug is generally recommended
for patients who have had an inadequate response to, or
are unable to tolerate, an alternate drug indicated for the
treatment of MS.
The efficacy of cladribine was shown in a clinical
trial in 1,326 patients with relapsing forms of MS who
had at least one relapse in the previous 12 months. The
drug significantly decreased the number of relapses
experienced by these patients compared to placebo.
Cladribine also reduced the progression of disability
compared to placebo.
romosozumab-aqqg
resulted in a significant
reduction of new vertebral
fracture at 12 months
compared to placebo.
This significant reduction
in fracture risk persisted
through the second year in
women who received the
drug during the first year and
transitioned to denosumab
compared to those who
transitioned from placebo to
denosumab.
In addition,
romosozumab-aqqg
significantly increased bone
mineral density at the
lumbar spine, total hip and
femoral neck compared
to placebo at 12 months.
Following the transition
from romosozumab-aqqg
to denosumab at month 12,
BMD continued to increase
through month 24.
In the active-controlled
ARCH study, treatment
with romosozumab-aqqg
for 12 months followed by
12 months of alendronate
significantly reduced the
incidence of new vertebral
fracture at 24 months.
May 2019 / FUTURE MEDICINE / 35