IMBRUVICA® is an oral, once-daily, single-agent therapy associated with a durable response in patients with this rare B-cell lymphoma
Toronto, ON – May 12, 2016 – Janssen Inc. announced today that Health Canada has issued a Notice of Compliance (NOC) for IMBRUVICA® (ibrutinib), an oral, once-daily, single-agent therapy for the treatment of patients with Waldenström’s macroglobulinemia (WM).1 Waldenström’s macroglobulinemia is a rare, incurable type of non-Hodgkin lymphoma, a cancer that begins in the body’s immune system.2,3
IMBRUVICA® was first approved in Canada in November 2014 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. In July 2015, IMBRUVICA® was approved with conditions for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL).
“Before now, treatment options for my patients with Waldenström’s macroglobulinemia have been limited,” said Dr. David Macdonald, MD, FRCPC, Assistant Professor, Dalhousie University, Hematologist, Capital Health. “The approval of IMBRUVICA® is a major advancement as this agent offers a targeted, chemotherapy-free treatment option for patients with WM, as it has done for those with other B-cell malignancies. It has shown clinically meaningful outcomes for these patients, as demonstrated by a high overall response rate.”
January 31, 2018
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