For more information or for interviews with medical specialists contact Gareth Finch gareth@palin.com.au
(0409 747 157) at Palin Communications (02 9412 2255).
MEDIA RELEASE
Attention National and Sydney-based health writers
New breast cancer treatment improves survival time
and reduces treatment side effects
A new nanoparticle chemotherapy listed on the Pharmaceutical Benefits Scheme shows
longer survival than a commonly used chemotherapy treatment in women with metastatic
breast cancer
Thursday 14 May 2009: A new treatment option for Australian women with metastatic breast cancer which
improves survival time and reduces the side effects of common chemotherapy treatment is set to be widely
available to Australian women now that is has been listed on the Pharmaceutical Benefits Scheme.
The new treatment is called Abraxane
®
(nanoparticle albumin-bound paclitaxel) and it is approved for the
treatment of metastatic carcinoma of the breast after the failure of anthracycline therapy (ie, chemotherapy)¹.
The published studies on which approval has been based describe Abraxane as an important advance in the
treatment of metastatic breast cancer². A study comparing Abraxane to solvent-based paclitaxel showed
women treated with Abraxane had superior overall efficacy, with significantly higher response rates, longer
time to disease progression and longer overall survival in pre-treated patients ¹
-2
.
Abraxane is the first solvent-free taxane available to women with metastatic breast cancer as a treatment
option, therefore eliminating solvent-induced toxicities such as severe hypersensitivity reactions and fatal
anaphylaxis
5
.
Over 100 Australian patients have already been treated with Abraxane free of charge following the launch of a
company-sponsored Abraxane Patient Access Program (APAP) which began in February 2009.
Australian medical oncologist Associate Professor Fran Boyle from the Mater Hospital in Sydney said that
new, more effective options are always welcomed by oncology specialists in Australia.
Many women have problems tolerating some existing chemotherapies, due to the corticosteroids required to
minimise severe hypersensitivity reactions so it is a pleasing addition to the oncologists drug armamentarium,
said Associate Professor Boyle. However, women who are currently deriving benefit from their existing
chemotherapy should not change their therapy. They should discuss this new treatment option with their
oncologist.
Leading Queensland oncologist Associate Professor Paul Mainwaring from The Mater Hospital in Brisbane
said he was pleased to see that the regulators had moved promptly to list Abraxane on the Australian PBS.
Abraxane has provided a much-needed new treatment option for women with metastatic breast cancer in the
USA. Abraxane has become the taxane therapy of choice for oncologists in the US in this setting so its good
news that we can now have the option of using it with our patients here in Australia, said A/Prof Mainwaring.
International oncologist Professor Hope Rugo from the University of California, San Francisco, says the
treatment is a welcome addition to the current range of breast cancer treatments available to Australian
women.
The key to better treatment is finding therapies that delay the advance of the tumour, improve patient survival
outcomes and, in the case of those chemotherapies that require pre-medication with corticosteroids, reducing
corticosteroid and solvent-related side effects. The published clinical data and clinical experience in the US
suggests Abraxane is going to satisfy those criteria, said Professor Rugo.
About ABRAXANE
®
ABRAXANE is a solvent-free, nanoparticle chemotherapy treatment option for metastatic breast cancer.
Developed using Abraxis BioScience's proprietary nab™ technology platform, ABRAXANE is a nanoparticle
protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human
protein, to deliver the drug and eliminate the need for solvents in the administration process. Nanoparticle
technology allows ABRAXANE to deliver a 49% higher dose compared to regular solvent-based paclitaxel
(Taxol
®
) without compromising safety and tolerability. In a previous randomized Phase III study of metastatic
breast cancer patients, ABRAXANE demonstrated nearly double the overall tumor response rate compared to
solvent-based paclitaxel and anthracycline pre-treated patients lived significantly longer
4
.
ABRAXANE is currently under Phase III investigation for the treatment of the following cancers: first-line
metastatic breast, non-small cell lung, malignant melanoma, and metastatic pancreatic.
Abraxane is now approved in over 35 countries including the U.S., Canada, European Union and China, and
more than 45,000 cancer patients have received Abraxane therapy in the past three years.
About Specialised Therapeutics, Pty Ltd
Specialised Therapeutics Australia Pty Ltd (STA) was established to identify and license innovative anti-cancer
and other specialised therapies for the Australasian market. Abraxane is the first of such therapies. Based in
Melbourne, Australia, the privately held company is currently negotiating the rights to several more important
therapeutic agents for distribution in Australia and New Zealand.
About Abraxis BioScience, Inc.
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery,
development and delivery of next-generation therapeutics and core technologies that offer patients safer and
more effective treatments for cancer and other critical illnesses. The company's portfolio includes the world's
first and only protein-bound nanoparticle chemotherapeutic compound (ABRAXANE), which is based on the
company's proprietary tumor targeting technology known as the nab
®
platform. The first FDA approved product
to use this nab
®
platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer.
Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the
PBS information: Authority Required: Metastatic breast cancer after failure of prior therapy which
includes an anthracycline.
Ends
Issued on behalf of Specialised Therapeutics Australia Pty Ltd.
For more information or for interviews with medical specialists call Gareth Finch (0409 747 157) at
Palin Communications (02 9412 2255).
1.
Abraxane Approved Product Information
2.
Gradishar WJ et al. J Clin Oncol 2005; 23: 7794- 7803
3.
Vukelja SJ et al. Efficacy of Nab-paclitaxel in patients with poor prognostic factors or with
anthracycline-resistant metastatic breast cancer (MBC). Abstract ASCO 2008;26:1082
4.
Guan Z et al. ASCO 2007: Abstract 1038
5.
Irizarry BA et al. Community Oncology 2008; 6: 132-134