Verzenios ® (abemaciklib)

För fullständig produktresumé för Verzenios se FASS.

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Verzenios® ▼ (abemaciclib): Tid till respons

Mediantiden till respons var 3,7 månader för abemaciclib i MONARCH 2 och 3,6 månader i MONARCH 3.

Summary

The pivotal study MONARCH 2 tested Verzenios in combination with fulvestrant, the pivotal study MONARCH 3 tested Verzenios in combination with aromatase inhibitors. 1

Table 1. Median Time to Response in the MONARCH Clinical Trials    presents the median time to response in the MONARCH clinical trials.

Table 1. Median Time to Response in the MONARCH Clinical Trials2-4

 

MONARCH 2

MONARCH 3

 

Abemaciclib + Fulvestrant

N=446

Placebo + Fulvestrant

N=223

Abemaciclib + NSAI

N=328

Placebo + NSAI

N=165

Median time to response, months

3.7

4.0

3.6

3.7

Abbreviation: NSAI = nonsteroidal aromatase inhibitor.

References

1. Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. 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. 2017;35(25):2875-2884. http://dx.doi.org/10.1200/JCO.2017.73.7585.

3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4. Johnston S, Martin M, Di Leo A, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019;5:5. http://dx.doi.org/10.1038/s41523-018-0097-z

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2019 M06 05

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