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): ER-/PR+ Patienter i MONARCH-Studierna

Patienter i MONARCH-studierna var skyldiga att ha hormonreceptorpositiv sjukdom. På grund av det lilla antalet patienter med ER-/PR+ finns inte analyser tillgängliga för denna undergrupp.

Detailed Information

In the MONARCH-2 and MONARCH-3 clinical trials, patients were required to have HR+ disease to be included in the studies.1,2

Patients in the MONARCH-2 and MONARCH-3 studies who were ER- and PR+ are presented in Table 1.

Table 1. ER-/PR+ Patients in the MONARCH-2 and MONARCH-3 Clinical Trials3

 

MONARCH 3

MONARCH 2

Abemaciclib + NSAI

Placebo + NSAI

Abemaciclib + Fulvestrant

Placebo + Fulvestrant

ITT, n

328

165

446

223

ER-/PR+, n

2

0

6

2

Abbreviations: ER- = estrogen receptor-negative; ITT = intent-to-treat; NSAI = nonsteroidal aromatase inhibitor; PR+ = progesterone receptor-positive.

Due to the small number of patients with ER-/PR+ disease, efficacy and safety analyses are not available for this subgroup.

References

1. 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

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.

Glossary

ER- = estrogen receptor-negative

HR+ = hormone receptor-positive

PR+ = progesterone receptor-positive

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 M05 15


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