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# Lilly Gains Approval for Verzenio for Breast Cancer
- URL: https://www.fdaweb.com/lilly-gains-approval-for-verzenio-for-breast-cancer/
- Published: 2017-09-28T12:00:00.000Z
- Updated: 2026-09-14T22:53:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139736

FDA has approved an Eli Lilly NDA for Verzenio (abemaciclib) for treating adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy. Verzenio is approved to be given in combination with fulvestrant. It is also approved as a single therapy if patients were previously treated with endocrine therapy and chemotherapy after the cancer metastasized.

Verzenio works by blocking certain molecules (cyclin-dependent kinases 4 and 6) involved in promoting cancer cell growth, an [FDA release ](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm578071.htm?ref=fdaweb.com)says. Approval was based on data from a trial involving 669 patients with HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and who had not received chemotherapy once the cancer had metastasized. “The median progression-free survival for patients taking Verzenio with fulvestrant was 16.4 months compared to 9.3 months for patients taking a placebo with fulvestrant,” it says.