Home' Australian Pharmacist : Australian Pharmacist Oct 2013 Contents 80
Australian Pharmacist October 2013 I © Pharmaceutical Society of Australia Ltd.
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The TGA has approved Erivedge
(vismodegib), an oral treatment for
adult patients with metastatic or locally
advanced basal cell carcinoma (BCC) where
surgery and/or radiation therapy are not
BCC is generally considered curable if
detected in its early stages.3 However, in
a small proportion of cases,3,4 the disease
progresses to an advanced stage and can
become potentially life-threatening, with
highly disfiguring lesions, often on the
head and neck, that cannot be effectively
treated with surgery or radiation.5,6,7
The approval of Erivedge was based on
results from ERIVANCE BCC (SHH4476g),
an international, single-arm, multicenter,
two-cohort, open-label, phase II study that
enrolled 104 patients with advanced BCC,
including locally advanced BCC (71) and
metastatic BCC (33).1,2
The study showed Erivedge shrank lesions
(objective response rate, or ORR) in 43%
(95% CI, P<0.001) of patients with locally
advanced BCC and 30% of patients (95% CI,
P=0.001) with metastatic BCC, the primary
endpoint of the study. The median duration
of response was 7.6 months.1
Professor Dedee Murrell, Head of
Department of Dermatology at St George
Hospital Sydney, has welcomed the
approval of Erivedge: ‘Research into skin
cancer has focused on melanoma and there
have been limited treatment options for
patients with advanced BCC. Until recently,
there were no approved medications
specifically for advanced BCC outside the
US, and traditional treatments for BCC, such
as surgery or radiation, can be ineffective or
inappropriate due to the disfiguring nature
– size, number and location – of the lesions.
The availability of an oral treatment for this
disease signals a step forward and offers
Australians with advanced BCC an option
where surgery is not appropriate.’
1. Sekulic A, et al. Efficacy and Safety of Vismodegib in Advance
Basel-Cell Carcinoma. The New England Jounral of Medicine;
2012; 366:2171-9 .
2. Erivedge (vismodegib) Product Information, May 2013.
Available at www.roche-australia.com/productinfo.
3. Tang JY, Epstein EH. Medical management of advanced
or metastatic basal cell carcinomas. AccessMedicine from
McGraw Hill 2010.
4. Joshi AD, et al. Demographic and treatment characteristics
for advanced basal cell carcinoma in an oncology out patient
setting. J Clin Oncol 2011; 29 (Suppl: abstract e19001)
5. Wong CSM, et al. Basal cell carcinoma. Brit Med J. 2003; 327
6. Amin SH, et al. Sparing the larynx and esophageal inlet
expedites feeding tube removal in patients with stage
III-IV oropharyngeal squamous cell carcinoma treated with
intensity-modulated radiotherapy. The Laryngoscope 2010;
7. O’Bryan KW, Ratner D. The Role of Targeted Molecular Inhibitors
in the Management of Advanced Nonmelanoma Skin Cancer.
Semin Cutan Med Surg 2011; 30: 57–61.
Bisolvon Chesty Forte
Boehringer Ingelheim, manufacturer
of Australia’s leading mucolytic brand
Bisolvon Chesty, has renamed its Bisolvon
Chesty Tablets and Soluble Tablets to
include “Forte” in the product description.
Bisolvon Chesty Forte Tablets and
Bisolvon Chesty Forte Soluble have the
same proven formula but with a new
product name and updated packaging.
These products contain 8mg bromhexine
per tablet, the same strength as Bisolvon
Chesty Forte Liquid per 5mL.
Sally Binfield, Senior Product Manager at
Boehringer Ingelheim, said pharmacy staff
should rest assured it is the same trusted
‘ The only changes have been to the name
and description of the products. There are
no changes to EAN codes, PDE codes or
pricing of the variants,’ Ms Binfield said.
‘ The inclusion of “Forte” will help
pharmacy staff easily identify Bisolvon
Chesty double strength 8mg bromhexine
products compared to other products in
‘ The new stock will be phased into
retail pharmacy in the coming months,’
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