Press Release: FDA approves Novartis Kisqali(R) -2-

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," "to reduce," "remains," "continue," "transform," "evaluate," "likelihood," "ensuring," "updates, " "should," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Kisqali in combination with an aromatase inhibitor (AI), or regarding potential future revenues from such product. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Kisqali in combination with an AI will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Kisqali in combination with an AI will be commercially successful in the future. In particular, our expectations regarding Kisqali in combination with an AI could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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References

1. Kisqali (ribociclib) Prescribing information. East Hanover, New Jersey,

USA: Novartis Pharmaceuticals Corporation; September 2024.

2. 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.

3. Slamon D, Stroyakovskiy D, Yardley D, et al. Ribociclib and endocrine

therapy as adjuvant treatment in patients with HR+/HER2- early breast

cancer: primary results from the Phase III NATALEE trial. Presented at

the American Society of Clinical Oncology Annual Meeting; June 2, 2023;

Chicago, USA.

4. Hortobagyi G, Stroyakovskiy D, Yardley DA, et al. Ribociclib (RIB) +

nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients

with HR+/HER2- early breast cancer: final invasive disease-free survival

(iDFS) analysis from the NATALEE trial. Presented at San Antonio Breast

Cancer Symposium (SABCS); December 8, 2023; San Antonio, USA.

5. Slamon D et al. Ribociclib plus Endocrine Therapy in Early Breast Cancer.

N Engl J Med. 2024;390:1080-1091. doi: 10.1056/NEJMoa2305488

6. Yardley D, Untch M, et al. Baseline (BL) characteristics and efficacy

endpoints for patients (pts) with node-negative (N0) HR+/HER2- early

breast cancer (EBC) in NATALEE. Presented at the American Society of

Clinical Oncology Annual Meeting; May 31, 2024; Chicago, USA.

7. 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.

8. Pan H et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping

Endocrine Therapy at 5 Years. N Engl J Med. 2017;377 (suppl 19):1836 846.

doi: 10.1056/NEJMoa1701830

9. Wangchinda P, Ithimakin S. Factors that predict recurrence later than 5

years after initial treatment in operable breast cancer. World J Surg

Oncol. 2016;14(1):223. doi: 10.1186/s12957-016-0988-0

10. 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.

11. 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.

12. 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

13. 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.

14. 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

15. 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

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

21. Iqbal J, Ginsburg O, Rochon PA, Sun P, Narod SA. Differences in breast

cancer stage at diagnosis and cancer-specific survival by race and

ethnicity in the United States [published correction appears in JAMA.

2015 Jun 9;313(22):2287]. JAMA. 2015;313(2):165-173.

doi:10.1001/jama.2014.17322

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September 17, 2024 12:55 ET (16:55 GMT)