Janssen-Cilag UK has announced that the European Commission (EC) has approved ibrutinib as a treatment option for adult patients with Waldenström’s Macroglobulinemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.¹

Prior to this decision there were no EC-approved treatment options available for patients with this rare and slow-growing blood cancer.²

WM is a rare type of slow-growing non-Hodgkin lymphoma.

It develops when plasma cells, specialised immune cells that produce antibodies, grow out of control.³

In the UK, over 400 patients each year are diagnosed with this disease, which is most prevalent in men over 65 years of age.⁴

WM accounts for approximately 2% of all B-cell lymphomas diagnosed in the UK each year.⁵

The incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.⁶

Dr Rebecca Auer, Clinical Senior Lecturer at Queen Mary University, said: “The EU licence for ibrutinib in Waldenström’s Macroglobulinemia is exciting, as it is the first licensed treatment for this rare disease in the UK. Ibrutinib is an oral and chemotherapy free approach, which has a good response rate and a generally well tolerated safety profile in clinical trials.⁷ This is particularly important because drug toxicities can have such a significant impact on a patient’s quality of life.”

References

1. Ibrutinib licence. European Commission

2. Garcia-Sanz R, Ocio EM. Novel treatment regimens for Waldenström’s macroglobulinemia. Expert Rev Hematol. 2010;3:339-50.

3. Macmillan. Waldenstrom’s Macroglobulinaemia. Available at http://www.macmillan.org.uk/information-and-support/lymphoma/lymphoma-non-hodgkin/types-of-non-Hodgkin-lymphoma/waldenstroms-macroglobulinaemia.html. Last accessed July 2015.

4. Waldenstroms Macroglobulinaemia UK. What is WM? Available at http://www.wmuk.org.uk/about-wm/what-is-wm. Last accessed July 2015.

5. Cancer Research UK. Different types of non-Hodgkin lymphoma. Available at http://www.cancerresearchuk.org/about-cancer/type/non-hodgkins-lymphoma/about/types/the-most-common-types-of-non-hodgkins-lymphoma. Last accessed July 2015.

6. 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.

7. Treon SP, Tripsas CK, Meid K, et al. Ibrutinib in previously treated Waldenström’s macroglobulinemia. N Engl J Med. 2015;372:1430-40.

 Source: Janssen