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Health Canada Approves IMBRUVICA

IMBRUVICA® is an oral, once-daily, single-agent therapy associated with a durable response in patients with this rare B-cell lymphoma

TORONTOMay 12, 2016 /CNW/ – 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.”

This approval for WM is based on an investigator-led, multicenter, prospective, single-arm study in 63 patients who had received at least one prior therapy. The results of the study were published in the New England Journal of Medicine in 2015 by Treon SP, et al.4

The median age of patients was 63 (range of 44-86 years old) and the median number of prior therapies was two (range of 1-11).5 Patients received IMBRUVICA® 420 mg once daily. After a median duration of follow-up of 14.8 months, IMBRUVICA® was associated with a 87.3 per cent overall response rate (ORR; the primary endpoint), and a 69.8 per cent major response rate as assessed by investigators using criteria adopted from the Third International Workshop on Waldenström’s Macroglobulinemia.6 The median time for patients to achieve at least a minor response to treatment was one month. 7 The median duration of response had not been reached.8

The most common adverse reactions in patients (≥20 per cent) were diarrhea, neutropenia, rash, nausea, muscle spasms, and fatigue.9  Four (six per cent) of patients discontinued treatment due to adverse events.10  Overall, IMBRUVICA® was well-tolerated and the safety profile was consistent with that observed in CLL and MCL.

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