Eli Lilly’s Verzenio label expanded by FDA for early breast cancer patients
Clinical ResultDrug ApprovalAccelerated Approval
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Source: PMLiVE
Eli Lilly and Company (Lilly) has said that the US Food and Drug Administration (FDA) has approved an expanded indication for Verzenio (abemaciclib), in combination with endocrine therapy (ET), as an additional treatment for certain patients with high risk early breast cancer.
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.
A significant benefit in invasive disease-free survival (IDFS) beyond the two-year treatment course was also observed in the Verzenio plus ET treatment group, the company said.
At four years, 85.5% of patients remained recurrence-free with the combination, compared to 78.6% with ET alone, an absolute difference in IDFS of 6.9%. At two years and at three years, the absolute differences between treatment groups were 3.1% and 5.0%, respectively.
More than 300,000 people in the US are expected to be diagnosed with breast cancer in 2023, with an estimated 90% of all cases detected at an early stage.
Although the prognosis for HR-positive, HER2-negative early breast cancer is typically favourable, high risk patients are around three times more likely than those with low risk characteristics to experience recurrence, with the majority being incurable metastatic disease.
Erika Hamilton, medical oncologist, director of breast and gynaecologic cancer research at Sarah Cannon Research Institute, and an investigator on the monarchE clinical trial, said: "The initial Verzenio FDA approval in early breast cancer was practice-changing and now, through this indication expansion, we have the potential to reduce the risk of breast cancer recurrence for many more patients, relying solely on commonly utilised clinicopathologic features to identify them."
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