TGA approves new breast cancer drug

A new drug shown to significantly reduce the risk of cancer recurrence or death in an aggressive form of breast cancer has been approved for use in Australian patients.

The drug, Nerlynx (neratinib), is an oral medication taken for 12 months by women with early stage HER2-positive (HER2+) breast cancer. It is now TGA approved with the following indication:

“Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab based therapy.”

The greatest benefit is seen in women who are hormone-receptor positive (HR+) and who initiate Nerlynx therapy within 12 months of completing trastuzumab based therapy. Their five-year risk of recurrence or death is reduced by 42 per cent after completing 12 months of Nerlynx therapy.

Breast Cancer Research Centre Oncologist Professor Arlene Chan, an international breast cancer authority, described the TGA approval of Nerlynx as “a huge step forward”, noting that women diagnosed with HER2+ breast cancer have a one-in-four chance of cancer recurrence even after surgery, chemotherapy and trastuzumab-based therapy.

Professor Chan says she expects that the availability of this new therapy will provide some Australian women with an opportunity to avoid experiencing a breast cancer recurrence.

“I’m absolutely delighted that Nerlynx has been approved for use in Australia,” she said.

“This is a huge benefit for women with this disease. The ability to improve the lives and reduce the risk of relapse will be enormously appreciated by many, many people in Australia.

“I would say that any proven treatment able to reduce the risk of cancer recurring has to be a win. Those women who are spared an invasive relapse will be eternally grateful that they’ve received this drug.”

Nerlynx is being made available in Australia and across South-East Asia by independent pharmaceutical company Specialised Therapeutics Asia (STA) in partnership with the drug’s US developer, Puma Biotechnology.

STA CEO Carlo Montagner says Nerlynx represents a new stage of treatment for Australian women and is being made available to Australia at no cost via the Nerlynx access program. He also says a reimbursement application has been submitted to the Pharmaceutical Benefits Advisory Committee and is under evaluation.

“This drug currently costs more than $200,000 for a full course of treatment over 12 months in North America,” he said.

“Our company is currently making Nerlynx available to appropriate women in Australia free of charge prior to PBS approval. However, we’re concerned many eligible women may not be aware of this access program and therefore may be missing out on a potentially life-saving treatment.

“With this TGA approval, this is the first time Australian women are being presented with an opportunity for extended-adjuvant therapy that will reduce the risk of disease recurrence in some women who would otherwise have had a relapse.

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