The EU approval means that a subset of individuals with breast cancer who would formerly have been deemed to have HER2-negative tumours – and so be excluded from a HER2-directed therapy – will now have a treatment option.
In Europe, approximately 531,000 breast cancer patients are diagnosed annually, with around 141,000 deaths, and around half of all cases would fall under the HER2-low classification, split between patients with both hormone receptor (HR)-positive and HR-negative disease.
