Application submitted to the EMA to expand the therapeutic indication for IMBRUVICA® (ibrutinib) to include treatment of Waldenström’s macroglobulinemia

IMBRUVICA is a first-in-class, once-daily, oral Bruton’s tyrosine kinase (BTK) inhibitor. IMBRUVICA is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics Switzerland GmbH. Janssen affiliates market IMBRUVICA in EMEA (Europe, Middle East and Africa) as well as the rest of the world, except for the United States, where both companies co-market it. 

“At Janssen, we strive to develop innovative products that prolong and improve patients’ lives,” said Thomas Stark, Vice President Medical Affairs, Janssen EMEA. “This additional application for IMBRUVICA, for the treatment of Waldenström’s macroglobulinemia, is an important milestone for patients suffering from the disease who currently have limited treatment options in Europe. If approved, IMBRUVICA has the potential to address a high unmet need among patients with this difficult to treat blood cancer.” 

WM (also known as IgM-excreting lymphoplasmacytic lymphoma) is a slow-growing and rare type of blood cancer^1,2 that originates from B cells, a type of white blood cell (lymphocyte) that develops in the bone marrow.^1,2 The median age at diagnosis is 63-68 years of age,^3,4 and incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.⁴ WM remains an incurable disease.^1,2

IMBRUVICA received European Commission approval in October 2014 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), and for adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.⁵ Janssen and Pharmacyclics are continuing an extensive clinical development programme for IMBRUVICA, including Phase 3 study commitments in multiple patient populations.

References

1. American Cancer Society. Detailed guide: Waldenstrom macroglobulinemia. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003148-pdf.pdf Accessed October 2014.
2. Leukemia and Lymphoma Society. Waldenström macroglobulinemia facts. Available at: http://www.lls.org/content/nationalcontent/resourcecenter/
   freeeducationmaterials/lymphoma/pdf/waldenstrommacroglobulinemia.pdf Last accessed November 2014.
3. Fonseca R, Hayman S. Waldenström macroglobulinaemia. Br J Haematol. 2007;138:700-20.
4. Buske C, Leblond V, Dimopoulos M, et al. Waldenström’s macroglobulinaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24(Suppl. 6):vi155–vi159.
5. European Medicines Agency. Committee for Medicinal Products for Human Use: Summary of opinion: Imbruvica. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003791/WC500170191.pdf. Accessed October 2014.