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BCNA News 19 Mar 2019

BCNA welcomes the TGA’s approval of Nerlynx (neratinib)

BCNA welcomes the Therapeutic Goods Administration’s (TGA) approval of the drug Nerlynx (neratinib) as a new treatment option for Australians diagnosed with HER2-positive, hormone receptor positive (HR-positive) early breast cancer.

Clinical trials have shown Nerlynx can reduce the five year risk of breast cancer returning by up to 42 per cent when Nerlynx is started within 1 year of completing Herceptin.

We know that the fear of breast cancer returning is something many women and men struggle with after treatment and this can have a significant impact on their emotional wellbeing and daily life.

It is a key priority for BCNA to ensure that new treatment options like Nerlynx – which have been shown in clinical trials to reduce the risk of a cancer recurrence – are approved for sale in Australia quickly and are put on the Pharmaceutical Benefits Scheme (PBS) so all women and men who could benefit from these new treatments can access them.

As BCNA CEO Kirsten Pilatti said in an interview with the Herald Sun, “Any treatment option that can reduce a woman's risk of recurrence is not just great from a cancer perspective but also from an emotional perspective.”

While Nerlynx is not yet listed on the PBS, the Pharmaceutical Benefits Advisory Committee (PBAC) is currently considering an application to add it. BCNA has provided a submission to PBAC in support of the listing, stressing the need for Nerlynx to be subsidised through the PBS so it is affordable for anyone who could benefit from it. 

While the PBAC considers the application for Nerlynx to be included on the PBS, the drug company that distributes Nerlynx has opened a compassionate access program to enable Australians with HER2-positive, HR-positive early breast cancer who have been treated with Herceptin in the past 12 months to receive Nerlynx at no cost. 

“Not all pharmaceutical companies provide a full compassionate access scheme, which gives women and men access to new drugs free of charge, and we want to acknowledge Specialised Therapeutics Australia for taking this step. BCNA would like to see this as standard practice for all new drug treatments,” said Kirsten.

“It’s also great to see that this access scheme has been opened straight after TGA approval so that Australians can access this drug right away. Women and men are used to hearing about new drugs and then experiencing a delay before they can afford to use them. BCNA would like to see this level of responsiveness become more common in Australia.”

If you were diagnosed with HER2-positive, HR-positive early breast cancer and have been treated with Herceptin in the past 12 months, you may like to speak to your medical oncologist about whether Nerlynx might be suitable for you.

More about Nerlynx

Nerlynx is an oral medication, which is taken daily for 12 months in conjunction with an aromatase inhibitor (AI). This means you can take it at home regardless of where you live.

Diarrhoea is a common side effect, especially in the first two months of starting treatment. However, anti-diarrhoeal medications have been found to help reduce the impact of diarrhoea. Your medical oncologist will be able to talk to you more about how to manage this side effect.

More information

  • You can read about the ExteNET clinical trial in The Lancet Oncology.
  • BCNA has developed videos and fact sheets to help you manage the fear of cancer returning which you can access via our website.