Verzenios ® (abemaciklib)

För fullständig produktresumé för Verzenios se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Verzenios® ▼ (abemaciclib): Tumörstadier i MONARCH

Patienter i de kliniska studierna med MONARCH hade avancerad eller metastaserad sjukdom.

Detailed Information

Abemaciclib is indicated for the treatment of women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.1

MONARCH Clinical Trials

These indications correspond with inclusion criteria in the MONARCH clinical trials. Patients in the MONARCH clinical trials were required to have

  • locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease in MONARCH 3 and

  • locally advanced disease not amenable to curative treatment by surgery or metastatic disease in MONARCH 2.2

In MONARCH 3, 11 (3.4%) out of 328 patients in the abemaciclib arm presented with locoregionally recurrent disease.3 

In MONARCH 2, 16 (3.6%) out of 446 patients in the abemaciclib arm presented with recurrent locally advanced disease.2

References

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

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

3. Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646. https://doi.org/10.1200/jco.2017.75.6155

Glossary

HR+ = hormone receptor-positive

HER2- = human epidermal growth factor receptor 2-negative

MBC = metastatic breast cancer

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 2020 M10 08


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