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FDA Approves Faslodex/Abemaciclib for HR+/HER2- Breast Cancer

Jason Harris
Published: Wednesday, Nov 15, 2017

Peter A. Kaufman, MD

Peter A. Kaufman, MD
The FDA has approved fulvestrant (Faslodex) for use in combination with the CDK4/6 inhibitor abemaciclib (Verzenio) to treat patients with HR+/HER2- advanced or metastatic breast cancer who have progressed after endocrine therapy.

The FDA approved single-agent fulvestrant in August 2017 for postmenopausal women with HR+/HER2- advanced breast cancer who have not received previous endocrine therapy. The drug had previously been approved as a single agent for HR+ patients following progression on endocrine therapy, and in combination with palbociclib (Ibrance) for the treatment of women with HR+/HER2-negative advanced or metastatic breast cancer who progressed following endocrine therapy.
Sledge GW, Toi M, Neven P, et al. MONARCH 2: Abemaciclib in combination with fulvestrant in women with HR+/HER2− advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 35:2875-2884.

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