Eli Lilly and Company — Verzenio FDA Review (NDA208716, ORIG 1, 2017)
Eli Lilly and Company · 2017 · FDA Review (openFDA) · company profile →
Report summary
The FDA review recommends approval for Eli Lilly's Verzenio (abemaciclib) for HR-positive, HER2-negative advanced or metastatic breast cancer. Approval is based on significant progression-free survival improvement in the MONARCH 2 trial (combination with fulvestrant) and objective response rate data from the MONARCH 1 trial (monotherapy). Nonclinical studies confirmed its CDK4/6 inhibition and identified target organs for toxicity. Clinical pharmacology established dosing, drug-drug interaction guidelines (especially with CYP3A modulators), and dose adjustments for tolerability. Key adverse events include diarrhea and neutropenia. The review also details trial designs, safety profiles, and labeling revisions, including warnings for embryo-fetal toxicity.
Key findings — cited to the page
| All grades diarrhea incidence for abemaciclib 200 mg monotherapy | 90 % | MONARCH 1 · p.71 |
| All grades neutropenia incidence for abemaciclib 200 mg monotherapy | 37 % | MONARCH 1 · p.71 |
| timeframe for Grade 3 or Grade 4 neutropenia occurrence | 20-35 days | · p.246 |
| Grade 3 diarrhea incidence for abemaciclib 200 mg monotherapy | 19.7 % | MONARCH 1 · p.71 |
| Grade 3 neutropenia incidence for abemaciclib 200 mg monotherapy | 18.9 % | MONARCH 1 · p.71 |
| median decrease in neutrophil production rate for fulvestrant + placebo arm | 5.41 % | · p.246 |
| median decrease in neutrophil production rate for fulvestrant + abemaciclib arm | 20.10 % | · p.246 |
| range of decrease in neutrophil production rate for fulvestrant + abemaciclib arm | 8.92-67.6 % | · p.246 |
| maximum percentage of MONARCH 2 patients experiencing Grade 3 or Grade 4 neutropenia | 23 % | MONARCH 2 · p.246 |
| 95% CI for maximum percentage of MONARCH 2 patients experiencing Grade 3 or Grade 4 neutropenia | 16-30 % | MONARCH 2 · p.246 |
| range of decrease in neutrophil production rate for fulvestrant + placebo arm | 3.37-27.7 % | · p.246 |
| Grade 3 diarrhea incidence for abemaciclib 200 mg | 19.0 % | MONARCH 2 · p.84 |
Source: Eli Lilly and Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →