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In the context of Abemaciclib & Breast Cancer / Mammacarcinoma (HR+ Her2-), abemaciclib is FDA‑approved for adult patients with Breast Cancer / Mammacarcinoma (HR+ Her2-) as monotherapy with prior endocrine therapy and chemotherapy in the metastatic setting (1, 4, 5, 6).
EMA approval for abemaciclib does not include monotherapy in Breast Cancer / Mammacarcinoma (HR+ Her2-) (7).
A study that combined data from the single-arm trial MONARCH 1 and the randomized trials MONARCH 2 and 3, involving a total of 900 patients, found that patient-reported outcomes (PROs) were identified as prognostic factors fo…