24.10.2024 07:14:47
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Press Release: Novartis ribociclib (Kisqali(R)) -2-
References
1. NCCN Guidelines. NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines(R)) - Breast Cancer. Accessed October 2024.
https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
2. Fasching PA. Adjuvant Ribociclib (RIB) Plus Nonsteroidal Aromatase
Inhibitor (NSAI) in Patients (Pts) With HR+/HER2- Early Breast Cancer
(EBC): 4-Year Outcomes From the NATALEE Trial. LBA13. Proffered Paper
presented at the European Society for Medical Oncology Congress;
September 16, 2024; Barcelona, Spain.
3. Tarantino P, Rugo HS, Curigliano G, et al. Characteristics of real-world
NATALEE and monarchE eligible populations: A US electronic health records
database analysis. Poster presented at the European Society for Medical
Oncology Congress; September 13-17, 2024; Barcelona, Spain.
4. Kisqali (ribociclib) Prescribing information. East Hanover, New Jersey,
USA: Novartis Pharmaceuticals Corporation; October 2024.
5. Kisqali. Summary of product characteristics (SmPC). Novartis Europharm
Limited; 2017. Accessed September 2024.
https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf.
6. Yardley DA, Yap YS, et al. Pooled exploratory analysis of survival in
patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral
metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET)
in the MONALEESA (ML) trials. Poster presented at the European Society of
Medical Oncology Congress; September 9-13, 2022; Paris, France.
7. Neven P, Fasching PA, et al. Updated overall survival (OS) results from
the first-line (1L) population in the Phase III MONALEESA-3 trial of
postmenopausal patients with HR+/HER2- advanced breast cancer (ABC)
treated with ribociclib (RIB) + fulvestrant (FUL). Mini oral presented at
the European Society for Medical Oncology Breast Cancer Congress; May 4,
2022; Paris, France.
8. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with
Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med.
2022;386(10):942-950. doi:10.1056/NEJMoa2114663
9. Hortobagyi GN, et al. Overall survival (OS) results from the phase III
MONALEESA (ML)-2 trial of postmenopausal patients with hormone receptor
positive/human epidermal growth factor receptor 2 negative (HR+/HER2-)
advanced breast cancer (ABC) treated with endocrine therapy (ET) +/-
ribociclib. Proffered paper presented at the European Society of Medical
Oncology Congress; September 16-21, 2021; Lugano, Switzerland.
10. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus
endocrine therapy in breast cancer. N Engl J Med. 2019;381(4):307-316.
doi:10.1056/nejmoa1903765
11. Slamon DJ, Neven P, Chia S, et al. Overall Survival with Ribociclib plus
Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020;382(6):514-524.
doi:10.1056/NEJMoa1911149
12. Slamon DJ, Neven P, Chia S, et al. Overall survival (OS) results of the
Phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone
receptor--positive (HR+), human epidermal growth factor 2--negative
(HER2-) advanced breast cancer (ABC) treated with fulvestrant (FUL) +/-
ribociclib (RIB). Presented at the European Society of Medical Oncology
Congress; September 29, 2019; Barcelona, Spain.
13. Slamon DJ, Neven P, Chia S, et al. Updated overall survival (OS) results
from the Phase III MONALEESA-3 trial of postmenopausal patients (pts)
with HR+/HER2- advanced breast cancer (ABC) treated with fulvestrant
(FUL) +/- ribociclib (RIB. Presented at the American Society of Clinical
Oncology Annual Meeting; June 5, 2021; Chicago, USA.
14. Tripathy D, Im S-A, Colleoni M, et al. Updated overall survival (OS)
results from the phase III MONALEESA-7 trial of pre- or perimenopausal
patients with HR+/HER2- advanced breast cancer (ABC) treated with
endocrine therapy (ET) +/- ribociclib. Presented at the San Antonio
Breast Cancer Symposium; December 9, 2020; San Antonio, USA.
15. Yardley D, Nusch A, Yap YS, et al. Overall survival (OS) in patients
(pts) with advanced breast cancer (ABC) with visceral metastases (mets),
including those with liver mets, treated with ribociclib (RIB) plus
endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented
at the American Society of Clinical Oncology (ASCO) Annual Meeting; June
2020; Chicago, USA.
16. O'Shaughnessy J, Stemmer SM, Burris HA, et al. Overall survival subgroup
analysis by metastatic site from the Phase III MONALEESA-2 study of
first-line ribociclib + letroz21ole in postmenopausal patients with
HR+/HER2- advanced breast cancer. Presented at the San Antonio Breast
Cancer Symposium; December 7-10, 2021; San Antonio, USA.
17. European Society for Medical Oncology -- Magnitude of Clinical Benefit
Scale Scorecard. Published April 20, 2020. Updated August 21, 2020.
Available at:
https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-158-1/.
Accessed September 2024.
18. European Society for Medical Oncology -- Magnitude of Clinical Benefit
Scale Scorecard. Published March 29, 2022. Available at:
https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-9-1/.
Accessed September 2024.
# # #
Novartis Media Relations
E-mail: media.relations@novartis.com
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Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
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(END) Dow Jones Newswires
October 24, 2024 01:15 ET (05:15 GMT)
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