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Position statements

CDK inhibitors for the treatment of hormone positive, HER2-negative metastatic breast cancer

UPDATE: Our palbociclib petition has closed. BCNA would like to extend its gratitude to the more than 32,000 Australians who signed the online petition for the Pharmaceutical Benefits Scheme (PBS) listing of palbociclib. Read our palbociclib petition update. 

Palbociclib is a targeted breast cancer therapy for the treatment of hormone positive, HER2-negative metastatic breast cancer, the most common subtype of breast cancer. Palbociclib belongs to a class of drugs called CDK inhibitors that work by blocking the function of enzymes involved in the pathway that helps control how cells grow and divide. These enzymes are commonly found in higher than normal amounts in breast cancer cells.

Palbociclib was approved for sale in Australia in May. While this is good news, it has not been approved for inclusion on the Pharmaceutical Benefits Scheme (the PBS). At a cost of around $5,000 per month, the reality is that most women who need it will be unable to afford it.

BCNA is running an online campaign to show the Australian Government how important it is that palbociclib becomes available on the PBS as soon as possible so that Australian women who may benefit from it can gain access to it in an affordable way. 

Other medicines belonging to the same class of drugs are also being tested around the world in women with breast cancer. This includes the drug ribociclib and a third drug called abemaciclib.

Ribociclib was recently approved by the FDA, the US drug regulatory authority, meaning that American women with this subtype of metastatic breast cancer can now access two different drugs that can potentially overcome or delay resistance to endocrine therapy in metastatic breast cancer. This can help delay women with hormone positive, HER2-negative breast cancer having to commence chemotherapy and all of the associated side effects that this can bring. An application has now been lodged for ribociclib to be made available in Australia.

Our position on all of the CDK inhibitors is that international clinical trials have shown that this class of drugs can have a tremendous impact on the length of time that metastatic breast cancer can be controlled for some women. Whilst our current campaign focuses on palbociclib as the first drug in this class to go before Australian regulators, BCNA will advocate for all of the CDK inhibitor drugs to become available to Australian women who may benefit from them and hope they will be listed on the PBS soon.

More information

Read BCNA submissions to the PBAC supporting the approval of: