FDA Expands Verzenio Indication to Forego Ki-67 Score in High-Risk, Early Breast Cancer


Removing the Ki-67 score to determine eligibility for Verzenio treatment in patients with HR-positive, HER2-negative, node positive, early breast cancer allows for more patients to receive this treatment.

The Food and Drug Administration (FDA) approved the expanded indication for Verzenio (abemaciclib) with endocrine therapy as adjuvant treatment (after primary treatment) of patients with HR-postivie, HER2-negative, node-positive, early breast cancer with a high risk for disease recurrence.

In particular, patients with a high risk for recurrence can be identified as eligible for Verzenio based on tumor size, nodal status and tumor grade (four or more positive nodes, or one to three positive nodes and at least a grade 3 tumor or one that is 5 centimeters or bigger), according to a press release from Eli Lilly, the drug’s manufacturer.

This expanded indication for adjuvant therapy with Verzenio now removes the Ki-67 score requirement to select patients. Ki-67 scoring in patients with breast cancer has been previously proposed as a clinical marker to guide treatment decisions by potentially predicting response to a given therapy.

Verzenio was originally approved by the FDA in 2021, marking the first CDK4/6 inhibitor approved for the treatment of patients with HR-positive, HER2-negative early breast cancer. At that time, eligibility for treatment with Verzenio required a Ki-67 score of at least 20% (considered a high score).

“Our goal in intensifying treatment for early breast cancer is to maintain remission and prevent the recurrence of cancer,” said Dr. Erika P. Hamilton, director of breast and gynecologic cancer research at Sarah Cannon Research Institute in Nashville, in the release. “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 utilized clinicopathologic features to identify them.”

The FDA based its decision to expand the indication for Verzenio on four-year data from the monarchE trial, which assessed the treatment in combination with endocrine therapy in this patient population, according to the release.

This combination contributed to a difference in invasive disease-free survival (the time after treatment ends that a patient survives without any signs or symptoms of that specific cancer) that grew over time; at four years, 85.5% of patients treated with Verzenio and endocrine therapy were free from disease recurrence compared with 78.6% treated with endocrine therapy alone.In fact, adding Verzenio to endocrine therapy reduced the risk for recurrence in these patients by 35% compared with treatment with endocrine therapy alone.

“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,” said Jacob Van Naarden, chief executive officer of Loxo@Lilly, in the release. “The initial adjuvant approval for Verzenio changed the treatment paradigm, and the strength of the monarchE results supporting this approval underscores the role this differentiated CDK4/6 inhibitor can play in reducing the risk of recurrence in early breast cancer.”

The most common side effects that occurred in at least 20% of patients from the monarchE trial were infections, diarrhea, fatigue, neutropenia, nausea, leukopenia, headache and anemia, according to the release.

“This expanded approval for Verzenio is welcome news to our community,” said Jean Sachs, chief executive officer of Living Beyond Breast Cancer, in the release. “A significant number of women and men have HR-positive, HER2-negative early breast cancer at high risk of returning. Making effective treatment options available is crucial to allowing people to make the best care decisions for themselves, together with their health care providers.”

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