FDA axes diagnostic requirement for Lilly's Verzenio + endocrine therapy in certain breast cancer patients
In the fall of 2021, when the FDA first authorized Eli Lilly’s CD4/6 inhibitor Verzenio plus endocrine therapy in early-stage HR-positive, HER2-negative breast cancer and at high risk of recurrence, the drug giant was limited in that patients had to have a Ki-67 score — a diagnostic test and staining technique that has been correlated to a worse prognosis in breast cancer patients — of at least 20%.
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