Profesionales sanitarios

La información contenida en este sitio internet está dirigida exclusivamente al profesional sanitario facultado para prescribir o dispensar medicamentos en España (requiere una formación especializada para su correcta interpretación).

Pierre Fabre Ibérica S.A. promueve la prescripción de sus productos farmacéuticos en condiciones establecidas en su ficha técnica.

Certifico que:

Soy profesional sanitario de la UE y he leído la información anterior, el aviso legal y la política de privacidad

Personal no sanitarios

Este es un sitio web internacional de NERLYNX® dedicado a los profesionales sanitarios.

No soy un profesional sanitario de la UE.

https://www.pierre-fabre.com/es-es

Pierre Fabre es responsable de la comercialización de NERLYNX en muchos países.

Pierre Fabre siempre ha favorecido un enfoque de la investigación basado en la colaboración, convencido de que la complementariedad y la puesta en común de conocimientos son aceleradores de la innovación. Puma Biotechnology y Pierre Fabre han firmado un acuerdo de licencia exclusiva en virtud del cual Pierre Fabre desarrollará y comercializará NERLYNX en numerosos países. A lo largo de los años, este acuerdo ha evolucionado, accediendo a una verdadera innovación para los pacientes en cada vez más territorios.

Los territorios indicados en azul son aquellos en los que Pierre Fabre posee la licencia de NERLYNX:

Europa: Alemania, Austria, Bélgica, Bulgaria, Chipre, Dinamarca, Eslovaquia, Eslovenia, España, Estonia, Finlandia, Francia, Grecia, Hungría, Irlanda, Islandia, Italia, Letonia, Liechtenstein, Lituania, Luxemburgo, Malta, Noruega, Países Bajos, Polonia, Portugal, Reino Unido, República Checa, Rumanía, Suecia, Suiza, Albania, Bosnia-Herzegovina, Croacia, Kosovo, República de Macedonia, Montenegro, Serbia

África: Túnez, Argelia, Marruecos, Burundi, República del Congo, Benín, Burkina Faso, Camerún, Chad, Costa de Marfil, Gabón, Guinea, Libia, Madagascar, Malí, Mauritania, Mauricio, Níger, Senegal, Togo, Yibuti, República Centroafricana, Egipto, Sudáfrica, Sudán

Asia: Irán, Irak, Arabia Saudí, Yemen, Siria, Jordania, Emiratos Árabes Unidos, Líbano, Omán, Kuwait, Qatar, Baréin, Turquía, China, Hong Kong, Taiwán, Macao

NERLYNX^® puede no estar aprobado y reembolsado en todos estos países. Consulte la información de prescripción local.

¿Dónde se produce NERLYNX?

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).

Este medicamento está sujeto a seguimiento adicional.

Referencias
1. Chan A, et al. Final Efficacy Results of Neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial. Clin Breast Cancer. 2021;21(1):80–91.
2. Chan A, et al. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016;17(3):367−377.
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, 2023. Available at: https://campuspierrefabre.com/wp-content/uploads/2023/07/NERLYNX_Ficha-te%CC%81cnica_-26.05.2023.pdf Accessed: July 2023.
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.
8. Cortazar P, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;383(9938):164−172
9. Collins DM, et al. Preclinical Characteristics of the Irreversible Pan-HER Kinase Inhibitor Neratinib Compared with Lapatinib: Implications for the Treatment of HER2-Positive and HER2-Mutated Breast Cancer. Cancers. 2019;11(6);737. doi:10.3390/cancers11060737.
10. Feldinger K and Kong A. Profile of neratinib and its potential in the treatment of breast cancer. Breast Cancer: Targets Ther. 2015;7:147–162.
11. Kourie HR, et al. Emerging treatments for HER2-positive early-stage breast cancer: focus on neratinib. OncoTargets Ther. 2017;10:3363–3372.
12. Wissner A and Mansour TS. The development of HKI-272 and related compounds for the treatment of cancer. Arch Pharm (Weinheim). 2008;341(8):465–477.
13. Canoici A, et al. Neratinib overcomes trastuzumab resistance in HER2 amplified breast cancer. Oncotarget. 2013;4(10):1592–1605.
14. Rabindran SK, et al. Antitumor activity of HKI-272, an orally active, irreversible inhibitor of the HER-2 tyrosine kinase. Cancer Res. 2004;64(11):3958–3965.
15. Iqbal N and Iqbal N. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;2014:852748.
16. Gutierrez C and Schiff R. HER 2: Biology, Detection, and Clinical Implications. Arch Pathol Lab Med. 2011;135(1):55–62.
17. Giuliano M, et al. Bidirectional Crosstalk between the Estrogen Receptor and Human Epidermal Growth Factor Receptor 2 Signaling Pathways in Breast Cancer: Molecular Basis and Clinical Implications. Breast Care. 2013;8:256–262.
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.
19. Harari D and Yarden Y. Molecular mechanisms underlying ErbB2/HER2 action in breast cancer. Oncogene. 2000;19:6102–6114.
20. Paplomata E, et al. Systemic Therapy For Early-Stage HER2-Positive Breast Cancers: Time for a Less-Is-More Approach? Cancer. 2015;121(4):517–526.
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.
25. National Cancer Institute. Diarrhoea and Cancer Treatment. Available at: https://www.cancer.gov/about-cancer/treatment/side-effects/diarrhoea. Accessed: June 2020.
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.
30. National Cancer Institute. Cancer Stat Facts: Female Breast Cancer Subtypes. https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed: June 2021.
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.

Este es un sitio web internacional de NERLYNX^®. IMPORTANTE: la información de este sitio web se basa en el resumen europeo de las características del producto. La información de prescripción y las indicaciones pueden variar según el país. Debe consultar la información de prescripción de su país. Tenga en cuenta que no nos hacemos responsables del acceso a dicha información, que puede no cumplir con la regulación o el uso en su país.

Última actualización: 08/2023