Home' Australian Pharmacist : Australian Pharmacist June 2015 Contents Australian Pharmacist June 2015 I ©Pharmaceutical Society of Australia Ltd.
MSD’s anti‐PD1 immunotherapy
Keytruda (pembrolizumab) has been
registered by the Therapeutic Goods
Administration (TGA) for the treatment
of advanced melanoma.
a prescription only medicine for the
treatment of unresectable or metastatic
melanoma in adults. Pembrolizumab
is the first anti‐PD‐1 immunotherapy
to obtain TGA approval in Australia
and uses the body’s immune system to
attack melanoma cells.
Professor Richard Kefford AM,
Professor of Cancer Medicine at
Macquarie University in Sydney, and
Co‐Director of Research at Melanoma
Institute Australia said: ‘Australia is the
melanoma capital of the world and
this new drug treatment is very much
needed. Pembrolizumab bolsters the
immunotherapy options available to
treat melanoma that has spread to other
skin sites, the lymph nodes or organs.’
Pembrolizumab is a humanised
monoclonal antibody that reactivates
the immune system to attack melanoma
cells by blocking the programmed cell
death protein 1, which left unchecked
allows cancer cells to pass undetected
by the body’s natural defences.
162 patients that received Keytruda
2mg/kg every three weeks, an overall
response rate of 37% (95% CI: 25, 50)
and disease control rate of 51% (95%
CI: 39,62; 6% complete response, 31%
partial response, 25% stable disease) by
RECIST 1.1 was demonstrated in patients
naïve to treatment with ipilimumab at
week 12.2 In patients previously treated
with ipilimumab, an overall response
was demonstrated in 26% (95% CI:
17, 37) and disease control rate of 51%
(95% CI: 39,63; 1% complete response,
25% partial response, 25% stable
disease) by RECIST 1.1.
1. MSD Australia. Approved Keytruda Product Information.
2. AIHW. Australia Cancer Incidence and Mortality Books:
Melanoma on the Skin. 2015. At: www.aihw.gov.au/
A transformational therapy for
Australians living with relapsing‐
remitting multiple sclerosis (MS),
Lemtrada (alemtuzumab), was PBS listed
on 1 April. It is a monotherapy option
for people with relapsing‐remitting
MS, with active disease as defined by
an MRI scan of the brain or spinal cord
and meet specific criteria. Lemtrada has
been shown to slow the accumulation
of physical disability and reduce the
frequency of clinical relapses.
It has an administration schedule of
two annual treatment courses. The first
treatment course is administered via
intravenous infusion on five consecutive
days, and the second course is
administered on three consecutive days,
12 months later. Approximately 70% of
patients in the phase III extension
studies did not require further treatment
Associate Professor John King, Senior
Neurologist at the Royal Melbourne
Hospital, who was an investigator on
the two phase III trials in Australia said:
‘In clinical trials following two treatment
courses, Lemtrada was found to slow
down the progression of physical disability
in people with relapsing forms of MS and
decrease the number of relapses.’
Lemtrada’s clinical development program
included two pivotal randomised phase
III studies comparing treatment with
alemtuzumab to high‐dose subcutaneous
interferon beta‐1a (Rebif) in patients with
relapsing‐remitting MS who had active
disease and were either new to treatment
(CARE‐MS I) or who had relapsed while on
prior therapy (CARE‐MS II), as well as an
ongoing extension study.
Mesalazine granules 3g sachets
for treatment of mild to moderate
ulcerative colitis (UC)
Aspen Australia is pleased to announce
that Salofalk granules 3g sachets have
received marketing approval and from
1 May 2015 will be PBS listed as an
intestinal anti‐inflammatory agent for
treatment of mild to moderate UC.
presentation complements our existing
Salofalk granule range and continues
to expand Aspen’s GI Health portfolio.
We can now offer 0.5g, 1g, 1.5g and 3g
sachets for added flexibility in dosing
Induction treatment of UC patients with
Salofalk 3g granules requires only one
sachet to be taken once daily (at an
induction dose of 3g/day) and can be
taken with meals.
PBS prescribing information will be
available at: www.pbs.gov.au/medicine/
item/10257W. Full Product Information
is located on the Aspen website: www.
1. Salofalk Granules Product Information Jun 2014.
2. PBS website, PBS Schedule Search, http://www.pbs.gov.
au/medicine/item/10257W [accessed 1/5/2015]
Salofalk® is a registered trademark of Dr. Falk
Pharma GmbH, used under license by Orphan
Australia Pty Ltd, a member of the Aspen Australia
group of companies. Aspen Pharma Pty Ltd, 34–36
Chandos Street, St Leonards NSW 2065.
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