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New Indication for Fulvestrant in Combination Therapy for Advanced Breast Cancer

By: Sarah Jackson
Posted: Thursday, November 16, 2017

The U.S. Food and Drug Administration (FDA) has approved a new indication for fulvestrant (Faslodex) in combination therapy with abemaciclib (Verzenio) for hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy, as announced by AstraZeneca on November 15, 2017. Fulvestrant was also approved by the European Commission for use in combination with another cyclin-dependent kinase 4/6 inhibitor—palbociclib (Ibrance)—for hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.

The approval was based on the randomized phase III MONARCH 2 trial, which included 669 women with hormone receptor–positive, HER2-negative advanced breast cancer who had already experienced disease progression on or after neoadjuvant or adjuvant endocrine therapy. Progression-free survival for those treated with fulvestrant and abemaciclib was 16.4 months compared with 9.3 months for those treated with fulvestrant and placebo. The most common adverse events associated with the combination therapy were diarrhea, neutropenia, nausea, and fatigue. For more on the MONARCH 2 trial, see the article by Sledge et al published in the Journal of Clinical Oncology.