FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Verzenio (abemaciclib)


HR+/HER2- advanced or metastatic breast cancer with disease progression following endocrine therapy as either monotherapy or in combination with fulvestrant. Monotherapy was approved for patients with prior chemotherapy in the metastatic setting, whereas combination therapy was approved in patients not treated with chemotherapy following endocrine therapy.


Inhibits cyclin-dependent kinase (CDKs) 4 and 6, thus interfering with cell cycle progression and cellular proliferation.


Monotherapy: 200 mg PO BID

Combination: 150 mg PO BID with fulvestrant (fulvestrant dose is 500 mg IM on days 1, 15, and 29, and then once monthly thereafter)


Monotherapy approval was based on MONARCH 1, a phase 2 single arm, open-labeled, multicenter study (n=132), after 1 or 2 chemotherapy treatments in the metastatic setting. Overall response rate (ORR) was 19.7%, with the median response duration of 8.6 months.

Combination with fulvestrant was approved based on MONARCH 2, a phase 3, double-blinded, placebo controlled, multicenter study (n=699). Median progression free survival (PFS) in the abemaciclib group was 16.4 months compared with 9.3 months for placebo. ORR was 48.1% compared with 21.3% for abemaciclib and placebo.


Dickler MN, et al. MONARCH 1, A phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer. Clin Cancer Res. 2017 Sep 1;23(17):5218-5224.

Sledge GW Jr, 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. 2017 Sep 1;35(25):2875-84.


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