FDA OKs new indication for Eli Lilly’s Verzenio
Eli Lilly has received the Food and Drug Administration’s green light for an expanded indication for Verzenio (abemaciclib). Verzenio, in combination with endocrine therapy, can be used for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive and early breast cancer at a high risk of recurrence. High-risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size and tumor grade (4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are ≥5 cm or Grade 3). This expanded adjuvant indication removes the Ki-67 score requirement for patient selection.
"Our goal in intensifying treatment for early breast cancer is to maintain remission and prevent the recurrence of cancer. The magnitude of benefit seen in the four-year data from the monarchE study reinforces my confidence in adjuvant Verzenio as the standard-of-care for high risk patients in this setting," said Erika P. Hamilton, medical oncologist, director of Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute, and an investigator on the monarchE clinical trial. "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."
"This expanded approval will allow us to bring Verzenio to many more women and men with HR+, HER2-, high risk early breast cancer in the curative setting—before patients experience recurrence, potentially to incurable metastatic disease," said Jacob Van Naarden, CEO of [email protected] "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."
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"This expanded approval for Verzenio is welcome news for our community," said Jean Sachs, CEO of Living Beyond Breast Cancer. "A significant number of women and men have HR+, HER2- 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 healthcare providers. We're pleased Verzenio will now be available to more people with this type of early breast cancer."
Concurrent with this expanded indication approval in EBC, the FDA has also broadened the indicated use of Verzenio in metastatic breast cancer when combined with an aromatase inhibitor as initial endocrine-based therapy for treating people with HR+, HER2- advanced or MBC. In addition, this updated MBC indication now includes all adult patients, with the expanded indication including pre-/perimenopausal women combined with ovarian suppression.
Verzenio is a targeted treatment known as a CDK4/6 inhibitor. Verzenio is a nonchemotherapy oral tablet.
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It is indicated for the following:
In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence;
In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer;
In combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy; and
As monotherapy for treating adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy.