FDA expands Verzenio approval for high-risk breast cancer
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The FDA expanded the approval of abemaciclib, combined with endocrine therapy, as adjuvant treatment for adults with hormone receptor-positive, HER2-negative, node-positive early breast cancer.
The label expansion removes the Ki-67 score requirement for selection of patients for treatment with abemaciclib (Verzenio, Eli Lilly), a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with high-risk disease who are eligible for abemaciclib can now be identified based on nodal status, tumor size and tumor grade (four or more positive nodes, or one to three positive nodes and tumors that are at least 5 cm and/or grade 3), according to prescribing information in an Eli Lilly press release.
Four-year results of the randomized phase 3 monarchE trial supported the expanded indication. The data, presented in December at San Antonio Breast Cancer Symposium and published in The Lancet Oncology, showed a 35% reduction in risk for recurrence compared with endocrine therapy alone (HR = 0.65; 95% CI, 0.567-0.753) among 5,637 adults with hormone receptor-positive, HER2-negative early-stage breast cancer at high risk for relapse, according to the press release. Updated safety findings appeared consistent with previous analyses.
“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 4-year data from the monarchE study reinforces my confidence in adjuvant Verzenio as the standard-of-care for high-risk patients in this setting,” Erika P. Hamilton, MD, medical oncologist, director of Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute, and a monarchE trial investigator, said in the press 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.”
FDA also broadened the indication for abemaciclib in metastatic breast cancer when combined with an aromatase inhibitor as first endocrine-based therapy for hormone receptor-positive, HER2-negative disease. This indication now includes all adults, including pre- and perimenopausal women when used with ovarian suppression, the press release stated.
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