COMUNICADO: Janssen envía la aplicación de autorización de marketing de daratumumab (y 3)

1) American Society of Clinical Oncology. Multiple myeloma: overview. Disponible a

través de: http://www.cancer.net/cancer-types/multiple-myeloma/overview. Ultimo acceso

18 de mayo de 2015.

2) Kumar, SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple

myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international

myeloma working group study. Leukemia. 2012;26(1):149-57.

3) Danylesko I, Beider K, Shimoni A, Nagler A. Monoclonal antibody-based immunotherapy

for multiple myeloma. Immunotherapy. 2012;4:919-38.

4) Ocio EM, Richardson PG, Rajkumar SV, et al. New drugs and novel mechanisms of action

in multiple myeloma in 2013: a report from the International Myeloma Working Group

(IMWG). Leukemia. 2014;28:525-542.

5) Lin P, Owens R, Tricot G, Wilson CS. Flow cytometric immunophenotypic analysis of 306

cases of multiple myeloma. Am J Clin Pathol. 2004;121:482-8.

6) Fedele G, di Girolamo M, Recine U, et al. CD38 ligation in peripheral blood

mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and

impaired secretion of IFNgamma cytokines and proliferation. Mediat Inflamm.

2013;2013:564687.

7) de Weers M, Tai YT, van der Veer MS, et al. Daratumumab, a novel therapeutic human

CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological

tumors. J Immunol. 2011;186:1840-8.

8) Lonial S, Weiss BM, Usmani SZ, et al. Phase 2 Study of daratumumab Monotherapy in

Patients with mayor o igual que3 Lines of Prior Therapy or Double Refractory Multiple

Myeloma (MM). J Clin Oncol. 2015;33(Suppl.):abstract LBA 8512.

9) Lokhorst HM, Plesner T, Laubach JP, et al. Targeting CD38 with Daratumumab Monotherapy

in Multiple Myeloma. N Engl J Med. 2015;Aug:1-13.

10) European Medicines Agency. Public Summary of Orphan Drug Designations - EU/3/13/1153.

Disponible a través de:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2013/08/huma

n_orphan_001232.jsp&mid=WC0b01ac058001d12b Ultimo acceso 12 de mayo de 2015.

11) GLOBOCAN 2012. Multiple myeloma. Disponible a través

de: http://globocan.iarc.fr/old/burden.asp?selection_pop=62968&Textp=Europe&selection

_cancer=17270&Text-c=Multiple+myeloma&pYear=13&type=0&window=1&submit=%C2%A0Execute. 

Ultimo acceso 13 de mayo de 2014.

12) American Cancer Society. Multiple myeloma: detailed guide. Disponible a través de:

http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf Ultimo acceso

18 de mayo de 2015.

13) Cancer Research UK. Myeloma Survival Statistics. Disponible a través de:

http://www.cancerresearchuk.org/cancer-info/cancerstats/types/myeloma/survival/multipl

e-myeloma-survival-statistics Ultimo acceso 18 de mayo de 2015.

14) Costa LJ, Gonsalves WI, Kumar SK. Early mortality in multiple myeloma. Leukemia.

2015;29:1616-8.

Consultas de medios: 

Natalie Buhl 

Móvil: +353(0)85-744-6696 

E-mail: nbuhl@its.jnj.com 

EmptyBreak:MARKER 

Relaciones con los inversores: 

Lesley Fishman 

Teléfono: +1-732-524-3922 

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Louise Mehrotra 

Teléfono: +1-732-524-6491 

Septiembre de 2015 

PHEM/DAT/0815/0002 

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Photo:

http://photos.prnewswire.com/prnh/20140324/NY88746LOGO 

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