Apr052016

Health Canada Approves ibrutinib for Waldenström's Macroglobulinemia

Health Canada has issued a Notice of Compliance (NOC) for ibrutinib (Imbruvica®), a promising oral therapy, for the treatment of patients with Waldenström's macroglobulinemia (WM).

Waldenström's macroglobulinemia (WM) is a rare type of B cell lymphoma with few effective treatment options. In Canada, approximately 150 new cases of WM are diagnosed each year. WM usually gets worse slowly over time and causes abnormal blood cells, known as B lymphocytes (B cells), to grow within the bone marrow, lymph nodes, liver, and spleen. In WM, abnormal B cells also overproduce a protein known as immunoglobulin M or IgM (macroglobulin) that may lead to excess bleeding, problems with vision and with the nervous system.

Health Canada has issued marketing authorization under the NOC policy for the treatment of patients with Waldenström's macroglobulinemia (WM).

Ibrutinib is approved in Canada for the treatment of patients with chronic lymphocytic leukemia (CLL), including those with 17p deletion, who have received at least one prior therapy, or for the frontline treatment of patients with CLL with 17p deletion (NOC), and for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL) (NOC/c).

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