Australia Leads the World in Funding Treatment for Early-stage Breast Cancer



Australia Leads the World in Funding Treatment for Early-stage Breast Cancer

Australia will be the first country in the world to fund Taxoterein combination with cyclophosphamide for women with earlystagebreast cancer,* as of 1 April 2010

Australia - 16 March 2010 - Sanofi-aventis announced today that all Australian women* will be able to access government funded Taxotere® (docetaxel) in combination with cyclophosphamide,1 a chemotherapy combination shown to benefit women's chances of surviving early-stage breast cancer.2,3 This follows a government decision to include Taxotere in combination with cyclophosphamide for this group of women on the Pharmaceutical Benefits Scheme (PBS)as of 1 April 2010.1

Dr Richard de Boer, Medical Oncologist at the Royal Melbourne and Western Hospitals, welcomed the government'sdecision to fund Taxotere in combination with cyclophosphamide, saying it represents an important advancement in themanagement of early-stage breast cancer.

Commenting on the decision to list this treatment option on the PBS, Dr de Boer said: "The government's decision to funda treatment that has been shown to benefit long-term survival is exciting news for Australian women with early-stagebreast cancer. From April 1 Australian women will be able to access a treatment that is affordable, accessible and hasbeen shown to improve their chances of surviving breast cancer in the long-term."

The new listing means that Taxotere-based chemotherapy will be available for the cost of a PBS script for Australianwomen with operable breast cancer1,4 - the only country in the world where this is the case.*

The Therapeutic Goods Administration (TGA) approved the use of Taxotere in combination with cyclophosphamide forwomen with early-stage breast cancer in August 2009.5 Prior to the government's decision, women with this stage ofcancer who wished to access the treatment paid approximately $8,000 - $9,000 for four treatment cycles.

Approximately one in nine Australian women will be diagnosed with breast cancer during her lifetime,6 and the number ofwomen diagnosed with breast cancer is expected to increase. In fact, Australian Government projections estimate thenumber of women diagnosed with breast cancer will reach 15,440 cases each year by 2015, which equates to 42 womenbeing diagnosed with breast cancer every day in 2015.6

"Breast cancer is the most common form of cancer affecting Australian women and is a significant cause of death, so anydecision to fund additional treatments which benefits survival is very welcome as it provides women with further choice,"said Assoc Prof Eva Segelov, Medical Oncologist at a major Sydney teaching hospital.

Dr Arlene Chan, Medical Oncologist at Perth's Mount Hospital, explained that the new PBS reimbursement is particularlyexciting as research has found that Taxotere in combination with cyclophosphamide improves survival of women withearly-stage breast cancer and reduces the risk of cancer recurrence, a serious concern for many women battling thedisease.2,3

Dr Chan commented on the new PBS reimbursement: "Having an effective non-anthracycline chemotherapy treatment isan important therapy advance, particularly for women with an underlying heart problem.""With Taxotere in combination with cyclophosphamide soon available on the PBS for early-stage breast cancer we havea treatment option that will help women reduce the chance of cancer recurrence," said Dr Chan. "This is a significantdevelopment given approximately one in five women with early-stage node-negative breast cancer will have their cancerreturn within 10 years."

Like all other chemotherapy medications that treat cancer, Taxotere may have side effects. Common side effects mayinclude infections, fluid retention, muscle pain or tenderness, joint pain, hair loss and tiredness.5

"Not all chemotherapy treatments are suitable for everyone, and different treatments affect individual women in differentways. It is important that women who are commencing chemotherapy treatment discuss the potential side effects andhow these can be managed with their doctor," said Dr Chan.



PBS information as of 1 April 2010:
PBS Information: Adjuvant treatment of operable breast cancer in combination with cyclophosphamide. NOTE: Amaximum of four cycles of treatment will be authorized under this restriction.For full Consumer Medicine Information please visit: http://www.pbs.gov.au/cmi/swctaxot10309.pdf
* Australia is the first country to register and reimburse Taxotere® (docetaxel) in combination with cyclophosphamide forthe treatment of early-stage node-negative breast cancer. The treatment has also been in reimbursed in one Canadianstate (Ontario). However the treatment is currently not funded or registered for use in any other parts of Canada.
About sanofi-aventis:
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions toimprove the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).For more information, please visit: www.sanofi-aventis.com

References
1. Data on file - sanofi-aventis. Correspondence from Pharmaceutical Evaluation Branch. 2010
2. Jones SE, Savin ME, Holmes FA et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamideas adjuvant therapy for operable breast cancer. JCO 1 December 2006; 24(34):5381-5387
3. Jones SE, Holmes FA, O'Shaughnessy J et al. Doxetaxel with cyclophosphamide is associated with an overall survival benefit comparedwith doxorubicin and cyclophosphamide: 7-year follow-up of US oncology research trial 9735. JCO 10 March 2009;27(8):1177-1183
4. UBM Media Australia. MIMS Australia. Dec 09/Jan 10;46(6):310-311
5. sanofi-aventis. Taxotere (docetaxel) Product Information. August 2009
6. Australian Institute of Health and Welfare and the National Breast and Ovarian Cancer Centre. Series 50 Breast cancer in Australia, anoverview 2009. Canberra: AIHW October 2009




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