Healthcare Professionals

This is an international website for NERLYNX® dedicated to Healthcare professionals

IMPORTANT: the information on this website is based on the European Summary of Product Characteristics. Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.

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This is an international website for NERLYNX® dedicated to Healthcare Professionals.

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heading-Nerlynx-Neratinib--HER2-Breast-Cancer-2

Possible clinical scenarios

Take one more step for additional protection with NERLYNX

Nerlynx-Neratinib--HER2+/HR+ early breast cancer- Adjuvant treatment history

Summary of the possible clinical scenarios taking into account therapeutic advances and acknowledging the different levels of evidence for NERLYNX use.³⁷

CT, chemotherapy; eBC, early breast cancer; HER2+, human epidermal growth factor receptor 2 positive; HR, hormone receptor; pCR, pathological complete response; T-DM1, trastuzumab emtansine.
*Following trastuzumab-based treatment in HER2+ eBC, upon integration with existing treatment guidelines and careful benefit/risk evaluation on an individual patient basis.³⁷

Learn about…

NERLYNX
Efficacy

NERLYNX
Safety

NERLYNX
Dosing

Contenu de la pop in (ici, un H3)

A noter que le contenu de la pop in est prise en compte pour le SEO.

Il est donc nécessaire de bien baliser les titres. Nous conseillons d'utiliser un H2 ou un H3 (pas de H1).

▼ 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.

References
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3. Martin M, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(12):1688−1700.
4. Holmes FA, et al. Continued efficacy of neratinib in patients with HER2-positive early-stage breast cancer. Final overall survival analysis from the randomized phase 3 ExteNET trial. Presented at the San Antonio Breast cancer Symposium. December 8-11, 2020. #PD3-03.
5. Nerlynx (neratinib 40 mg film-coated tablets) Summary of Product Characteristics, 2021. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/nerlynx. Accessed: Sept 2021.
6. Cameron D, et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the Herceptin Adjuvant (HERA) trial. Lancet. 2017;389:1195–1205.
7. Von Minckwitz G, et al. Trastuzumab Emtansine for residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019;380:617–628.
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18. Shou J, et al. Mechanisms of Tamoxifen Resistance: Increased Estrogen Receptor-HER2/neu Cross-Talk in ER/HER2–Positive Breast Cancer. J Natl Cancer Inst. 2004;96(12):926–935.
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21. Barcenas CH, et al. Improved tolerability of neratinib in patients with HER2-positive early-stage breast cancer: the CONTROL trial. Ann Oncol. 2020;31(9):1223−1230.
22. European Medicines Agency Public Assessment Report (EPAR). Nerlynx EMA/CHMP/525204/2018.
23. Barcenas CH, et al. CONTROL trial Supplementary Table S7, available at Ann Oncol online.
24. Cancer.Net. Doctor-Approved Patient Information from ASCO on Diarrhoea. Available at: https://www.cancer.net/coping-with-cancer/physical-emotional and-social-effects-cancer/managing-physical-side-effects/diarrhoea. Accessed: June 2020.
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26. Chan A, et al. Effect of prophylaxis or neratinib dose escalation on neratinib-associated diarrhoea and tolerability in patients with HER2-positive early stage breast cancer: phase II CONTROL trial. Poster P5-14-03 presented at SABCS 2019.
27. Mortimer J, et al. Patterns of occurrence and implications of neratinib-associated diarrhoea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial. Breast Cancer Res. 2019;21(1):32. Electronic Supplementary Material.
28. Pinter M, et al. Cancer and liver cirrhosis: implications on prognosis and management. ESMO Open. 2016:1(2)e000042. eCollection 2016.
29. Breastcancer.org. How to read hormone receptor test results. Available at: https://www.breastcancer.org/symptoms/diagnosis/hormone_status/read_results. Accessed: March 2021.
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31. Perez EA, et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011;29:3366–3373.
32. Perez EA, et al. Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32:3744–3752.
33. Goldhirsch A, et al. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomized controlled trial. Lancet. 2013;382:1021–1028.
34. Von Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;377:122–131.
35. Piccart M, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years’ Follow-Up. J Clin Oncol. 2021. doi:10.1200/JCO.20.01204. [Online ahead of print].
36. Piccart-Gebhart MJ, et al. Trastuzumab after Adjuvant Chemotherapy in HER2-Positive Breast Cancer. N Engl J Med. 2005;353(16):1659–1672.
37. Untch M, et al. How to Optimise Extended Adjuvant Treatment with Neratinib for HER2+ Early Breast Cancer Patients. Oncol Ther J. 2021.

This is an international website for NERLYNX®. IMPORTANT: the information on this website is based on the European Summary of Product Characteristics. Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.

Last update: 10/2021

Healthcare Professionals​