Verzenio® (Abemaciclib)

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Abemaciclib: Advanced and Metastatic Disease Staging

Patients in the MONARCH clinical trials had advanced or metastatic disease.

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Detailed Information

The information contained in this letter may not completely match the current local labeling for ABEMACICLIB. Please see local labeling approved in your country. 

Abemaciclib is approved for use

  • in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR+, HER2- advanced or MBC
  • in combination with fulvestrant for the treatment of women with HR+, HER2-, advanced or MBC with disease progression following endocrine therapy, and
  • as monotherapy for the treatment of adult patients with HR+, HER2- advanced or MBC with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.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,
  • locally advanced disease not amenable to curative treatment by surgery or metastatic disease in MONARCH 2, and
  • recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy in MONARCH 1.1

In MONARCH 3, 11 (3.4%) out of 328 patients in the abemaciclib arm presented with locoregionally recurrent disease.2 

In MONARCH 2, 16 (3.6%) out of 446 patients in the abemaciclib arm presented with recurrent locally advanced disease.1

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Goetz 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

Fecha de la última revisión: 2020 M10 08


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