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Janssen’s IMBRUVICA®▼ (ibrutinib) Receives Additional European Commission Approval for the Treatment of Waldenström’s Macroglobulinemia

11:35 EDT 21 Jul 2015 | BioPortfolio

Ibrutinib is now the first EC-approved treatment for this rare B-cell lymphoma

Janssen, High Wycombe – Friday 17th July – Janssen-Cilag UK (Janssen) announced today that the European Commission (EC) has approved IMBRUVICA®▼ (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.[i] Prior to this decision there were no EC-approved treatment options available for patients with this rare and slow-growing blood cancer.[ii]

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.[iii] In the UK, over 400 patients each year are diagnosed with this disease, which is most prevalent in men over 65 years of age.[iv] WM accounts for approximately 2% of all B-cell lymphomas diagnosed in the UK each year.[v] The incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.[vi]

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.[vii] This is particularly important because drug toxicities can have such a significant impact on a patient’s quality of life.”

Spokespeople available:
• Dr Rebecca Auer, Clinical Senior Lecturer at Queen Mary University
• Roger Brown, Chair of Waldenstrom’s Macroglobulinemia UK

If you require further information, please do not hesitate to contact Mark Seymour on 0207 861 2812/ 07824 475410 or Hannah Gazzard on 0207 861 2820 NEXT ARTICLE

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