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# FDA Priority Review on Lilly NDA for Abemaciclib
- URL: https://www.fdaweb.com/fda-priority-review-on-lilly-nda-for-abemaciclib/
- Published: 2017-07-12T12:00:00.000Z
- Updated: 2026-09-14T22:33:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139121

FDA has accepted for priority review an Eli Lilly NDA for abemaciclib, a cyclin-dependent kinase 4 & 6 inhibitor for two indications — monotherapy for patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease, and combination use with fulvestrant in women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy. This submission is based on data from the MONARCH 1 and MONARCH 2 studies. In 2015, the agency granted abemaciclib a breakthrough therapy designation based on data from a breast cancer cohort expansion of the company’s Phase 1 trial. Lilly expects a review decision in the first quarter of 2018.