Scotland Approves Neratinib (Nerlynx) for Breast Cancer

Nicky Broyd

August 11, 2020

The Scottish Medicines Consortium (SMC) has approved the oral biological breast cancer drug neratinib (Nerlynx, Pierre Fabre) for NHS funding.

The decision is the first to be published since the SMC paused its assessment work for COVID-19 and was expedited to help minimise delays.

Neratinib is a tyrosine kinase inhibitor and is approved as an option for early HER2-positive breast cancer in patients who have had surgery.

Neratinib can help reduce recurrence of the disease and is given following treatment with trastuzumab (Herceptin, Roche).

Data from the ExteNET clinical trial show 90.2% of patients taking neratinib after adjuvant trastuzumab were free of invasive disease 5 years later, compared to 87.7% of those in the placebo arm.

The recommended dose is 240mg once a day.


The SMC made its decision after a patient group submission from the charity Breast Cancer Now.

The charity's Chief Executive, Baroness Delyth Morgan, commented that it was "wonderful" that some patients will have access to an additional treatment.

"The fear of breast cancer returning or spreading to other parts of their body can cause women considerable anxiety and around a quarter of those with this type of early breast cancer experience a recurrence within 10 years. Trastuzumab has been one of the greatest advances in treating breast cancer in recent decades and now, for some patients with HER2 positive breast cancer, being able to continue treatment with neratinib offers an important option to help further reduce the chance of the disease returning," she said in a statement.

Around 166 Scottish patients a year are likely to be eligible for the new drug.

The National Institute for Health and Care Excellence (NICE) made its positive decision on the drug last November.


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