Press Release: Novartis ribociclib (Kisqali(R)) -2-

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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.

# # #

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(END) Dow Jones Newswires

October 24, 2024 01:15 ET (05:15 GMT)