The decision to remove the previous 20% Ki-67 score requirement for patient selection means that those with HR-positive, HER2-negative early breast cancer can now be identified solely based on nodal status, tumour size and tumour grade.
Jacob Van Naarden, chief executive officer of Loxo@Lilly, said: “This expanded approval will allow us to bring Verzenio to many more women and men with HR-positive, HER2-negative, high risk early breast cancer in the curative setting – before patients experience recurrence, potentially to incurable metastatic disease.”
The label expansion was supported by four-year data from the phase 3 monarchE trial, which showed the addition of Verzenio to ET reduced the risk of recurrence by 35% compared to ET alone.
