Home' Australian Pharmacist : Australian Pharmacist October 2014 Contents Australian Pharmacist October 2014 I ©Pharmaceutical Society of Australia Ltd.
Ribomustin (bendamustine hcl) is now
registered with The Therapeutic Goods
Administration (TGA) in Australia for the
treatment of a range of blood cancers.
The approved TGA indications are for:
• Previously untreated indolent CD20-
positive, stage III-IV Non-Hodgkin’s
lymphoma, in combination with
• Relapsed/refractory indolent
• Previously untreated CD20-positive,
stage III-IV mantle cell lymphoma
in combination with rituximab, in
patients ineligible for autologous
stem cell transplantation, and
• The first-line treatment of chronic
lymphocytic leukaemia (Binet stage
B or C). Efficacy relative to first-line
therapies other than chlorambucil has
not been established.
At this time, Ribomustin is not
reimbursed on the Pharmaceutical
Benefits Scheme for these indications.
With the addition of Ribomustin to the
Australian Register of Therapeutic Goods
(ARTG), this product is now available
for indicated patients without the need
to apply through the SAS program.
Should you have any questions, please
contact Janssen’s Medical Information
Department on 1800 226 334.
Gazyva (obinutuzumab, or GA101), a new
type II monoclonal antibody, has been
approved by the Therapeutic Goods
Administration (TGA) for previously
untreated chronic lymphocytic
leukaemia (CLL) in combination with
chlorambucil. This approval is significant
because it provides ‘typical’ CLL
patients – those with advanced age and
co-existing medical conditions – a new
option for treating their disease.
The TGA approval was based on data
from CLL11, a three-arm phase III
study which investigated the use
of Gazyva and chlorambucil versus
MabThera (rituximab) and chlorambucil
or chlorambucil alone in previously
untreated patients with CLL and
1,2 The study
showed that median progression-free
survival (PFS) was 26.7 months in the
Gazyva arm of the study and 15.2
months in the MabThera arm (p<0.001).2
Gazyva in combination with
chlorambucil also induced significantly
higher molecular response rates
(negative testing for minimal residual
disease) over MabThera in combination
with chlorambucil in the blood (37.7%
vs. 3.3%) and in the bone marrow (19.5%
vs. 2.6%) (p<0.001).
Associate Professor Stephen Opat
from Monash Health and the Faculty of
Medicine, Monash University, and an
author on CLL11, said this study is the
largest to have investigated therapy in
typical CLL patients.2-6
‘Gazyva plus chlorambucil is effective
in ‘filling the gap’ between aggressive
treatment more suitable for younger,
fitter patients and is a gentle treatment
for the frail elderly. There has been a
significant need for therapies appropriate
for patients aged 70 and over who have
co-existing medical conditions,’ Associate
Professor Opat said.
1. GAZYVA Approved Product Information. At: www.roche-
2. Goede V, Fischer K, et al. Obinutuzumab plus Chlorambucil
in patients with CLL and coexisting conditions. N Engl J
Med 2014; 370:1101–10.
3. Howlader N, et al. SEER cancer statistics review, 1975-2010.
National Cancer Institute website. Nov 2012. http://seer.
overview.pdf. Accessed Nov 2013.
4. Thurmes P et al. Comorbid conditions and survival in
unselected newly diagnosed patients with chronic
lymphocytic leukaemia. Leuk & Lymph 2008;49(1):49–56.
5. Clifford R, Schuh A. State-of-the-Art Management of
Patients Suffering from Chronic Lymphocytic Leukaemia.
Clin Med Insights Oncol 2012; 6:165–78.
6. Satram-Hoang S, et al. The Unmet Need in Chronic
Lymphocytic Leukaemia: Impact of Comorbidity Burden
on Treatment Patterns and Outcomes in Elderly Patients.
Journal of Cancer Therapy, 2013; 4:1321–9 .
7. Gribben JG () Chronic lymphocytic leukaemia: planning
for an aging population. Expert Rev Anticancer Ther
CareDent has launched InterBrush,
Australia’s only wire free dental
brush designed to thoroughly clean
interproximal spaces, the hard to
reach places between teeth. The
soft rubber bristles are gentle and
flexible, ideal for hard to reach spaces,
around bridges, implants, crowns and
Dr Dinesh Sanmuganathan, of
Orthodontics at Tamworth said:
‘Interdental brushes help to eliminate
fragments of food and build-up of tooth
plaque between teeth which can protect
against periodontal health problems.
CareDent’s InterBrush is an effective
alternative to flossing and many of my
patients find it to be gentler on teeth
and gums, and can give a significantly
CareDent InterBrush is available in three
sizes to help reach the different sized
gaps between teeth.
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