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24.06.2022 13:12:48

Press Release: Novartis receives positive CHMP -2-

Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews https://twitter.com/novartisnews

For Novartis multimedia content, please visit https://www.novartis.com/news/media-library https://www.novartis.com/news/media-library

For questions about the site or required registration, please contact media.relations@novartis.com

*Bosulif is a registered trademark of Pfizer

References

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STAMP Inhibitor, vs Bosutinib in CML After>= 2 Prior TKIs. Blood. 2021.

DOI: 10.1182/blood.2020009984. PMID: 34407542.

2. Hoffmann, V., Baccarani, M., Hasford, J. et al. The EUTOS

population-based registry: incidence and clinical characteristics of 2904

CML patients in 20 European Countries. Leukemia 29, 1336--1343 (2015).

https://doi.org/10.1038/leu.2015.73

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pitfalls and new therapeutic possibilities. Drug Des Devel Ther.

2019;13:825-843.

4. Akard LP, et al. The "Hit Hard and Hit Early" Approach to the Treatment

of Chronic Myeloid Leukemia: Implications of the Updated National

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Practice. Clin Adv Hematol Oncol. 2013;11(7):421-432.

5. Cortes JE, et al. Long-term bosutinib for chronic phase chronic myeloid

leukemia after failure of imatinib plus dasatinib and/or nilotinib. Am J

Hematol. 2016;91(12):1206-1214.

6. Cortes JE, et al. Ponatinib efficacy and safety in Philadelphia

chromosome--positive leukemia: Final 5-year results of the phase 2 PACE

trial. Blood. 2018;132(4):393-404.

7. Garg RJ, et al. The use of nilotinib or dasatinib after failure to 2

prior tyrosine kinase inhibitors: long-term follow-up. Blood.

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chronic myeloid leukemia. Leukemia. 2020;34:966-984

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Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia

Patients Trial. J Clin Oncol. 2016;34:2333-2340.

10. Steegmann JL., et al. European LeukemiaNet recommendations for the

management and avoidance of adverse events of treatment in chronic

myeloid leukaemia. Leukemia. 2016;30:1648-1671.

11. Giles FJ, et al. Nilotinib is active in chronic and accelerated phase

chronic myeloid leukemia following failure of imatinib and dasatinib

therapy. Leukemia. 2010; 24(7):1299--1301.

12. Kantarjian HM, et al. Nilotinib is effective in patients with chronic

myeloid leukemia in chronic phase after imatinib resistance or

intolerance: 24-month follow-up results. Blood. 2010;117(4):1141-1145.

doi:10.1182/blood-2010-03-277152.

13. Shah NP, et al. Potent, transient inhibition of BCR-ABL with dasatinib

100 mg daily achieves rapid and durable cytogenetic responses and high

transformation-free survival rates in chronic phase chronic myeloid

leukemia patients with resistance, suboptimal response or intolerance to

imatinib. Haematologica. 2010 Feb;95(2):232-40. doi:

10.3324/haematol.2009.011452. PMID: 20139391; PMCID: PMC2817025.

14. Gambacorti-Passerini C, et al. Bosutinib efficacy and safety in chronic

phase chronic myeloid leukemia after imatinib resistance or intolerance:

Minimum 24-month follow-up. Am J Hematol. 2014 Jul;89(7):732-42. doi:

10.1002/ajh.23728. Epub 2014 Apr 28. PMID: 24711212; PMCID: PMC4173127.

15. Cortes JE, et al. Oral presentation at ASCO 2022; June 3-7, 2022. Chicago

IL and virtual. Abstract 7004

16. Réa D, et al. Oral presentation at EHA 2022; June 9-17, 2022. Vienna

Austria and virtual. Abstract S155

17. Wylie AA, et al. The allosteric inhibitor ABL001 enables dual targeting

of BCR--ABL1. Nature. 2017;543(7647):733-737.

18. Schoepfer J, et al. Discovery of Asciminib (ABL001), an Allosteric

Inhibitor of the Tyrosine Kinase Activity of BCR-ABL1. J Med Chem.

2018;61(18):8120-8135.

19. Hughes TP, et al. Asciminib in Chronic Myeloid Leukemia after ABL Kinase

Inhibitor Failure. N Engl J Med. 2019; 381(24):2315-2326.

20. Hughes TP, et al. Expanded Phase 1 Study of ABL001, a Potent, Allosteric

Inhibitor of BCR-ABL, Reveals Significant and Durable Responses in

Patients with CML-Chronic Phase with Failure of Prior TKI Therapy. Poster

presented at: ASH Annual Meeting & Exposition; Dec. 5, 2016.

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Exhibits Safety and Promising Single- Agent Activity in a Phase I Study

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22. Mauro MJ, et al. Combination of Asciminib Plus Nilotinib (NIL) or

Dasatinib (DAS) in Patients (PTS) with Chronic Myeloid Leukemia (CML):

Results from a Phase 1 Study. Poster presented at: EHA Annual Meeting;

June 15, 2019.

23. Cortes JE, et al. Combination Therapy Using Asciminib Plus Imatinib (IMA)

in Patients (PTS) with Chronic Myeloid Leukemia (CML): Results from a

Phase 1 Study. Poster presented at: EHA Annual Meeting; June 15, 2019.

24. ClinicalTrials.gov. 2017. Study of Efficacy of CML-CP Patients Treated

with ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs.

[online] Available at: https://clinicaltrials.gov/ct2/show/NCT03106779.

25. ClinicalTrials.gov. 2021. A Study of Oral Asciminib Versus Other TKIs in

Adult Patients With Newly Diagnosed Ph+ CML-CP. [online] Available at:

https://clinicaltrials.gov/ct2/show/NCT04971226.

26. ClinicalTrials.gov. 2020. Asciminib in Monotherapy for Chronic Myeloid

Leukemia in Chronic Phase (CML-CP) With and WithoutT315I Mutation

(AIM4CML). [online] Available at:

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27. ClinicalTrials.gov. 2018. Study of Efficacy And Safety Of Asciminib In

Combination With Imatinib In Patients With Chronic Myeloid Leukemia In

Chronic Phase (CML-CP). [online] Available at:

https://clinicaltrials.gov/ct2/show/NCT03578367.

28. ClinicalTrials.gov. 2021. Study of Efficacy and Safety of CML-CP Patients

Treated With Asciminib Versus Best Available Therapy, Previously Treated

With 2 or More Tyrosine Kinase Inhibitors. [online] Available at:

https://clinicaltrials.gov/ct2/show/NCT04795427.

29. ClinicalTrials.gov. 2014. A Phase I Study of Oral ABL001 in Patients With

CML or Ph+ ALL. [online] Available at:

https://clinicaltrials.gov/ct2/show/NCT02081378.

30. ClinicalTrials.gov. 2021 Asciminib Treatment Optimization in >= 3rd Line

CML-CP. [online] Available at:

https://clinicaltrials.gov/ct2/show/NCT04948333

31. ClinicalTrials.gov. 2021. Study to Determine the Dose and Safety of

Asciminib in Pediatric Patients With Chronic Myeloid Leukemia [online]

Available at: https://clinicaltrials.gov/ct2/show/NCT04925479

32. Scemblix [prescribing information]. East Hanover, NJ: Novartis

Pharmaceuticals Corp; 2021.

# # #

Novartis Media Relations

E-mail: media.relations@novartis.com

Amy Wolf Floriana Riccio Furnari

Novartis External Communications Novartis Oncology Communications

+41 79 576 0723 (mobile) +1 862 778 1866 (direct)

amy.wolf@novartis.com +1 862 210 5317 (mobile)

Julie Masow floriana.riccio_furnari@novartis.com

Novartis US External Communications

+1 862 579 8456

julie.masow@novartis.com

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@novartis.com

Central North America

Samir Shah +41 61 324 7944 Sloan Simpson +1 862 345 4440

Nicole Zinsli-Somm +4 16 132 43809 Alina Levchuk +1 862 778 3372

Isabella Zinck +41 61 324 7188 Parag Mahanti +1 973-876-4912

(END) Dow Jones Newswires

June 24, 2022 07:13 ET (11:13 GMT)


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