IMBRUVICA® (ibrutinib) Approved with Conditions for Relapsed or Refractory Mantle Cell Lymphoma Patients

Oral, once-daily, single-agent therapy fills an unmet need for new treatment options to help Canadians in the fight against this deadly disease

TORONTO, July 30, 2015 /CNW/ - Janssen Inc. announced today that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for IMBRUVICA® (ibrutinib) an oral, once-daily single-agent therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL).1 The approval with conditions is based on phase 2 clinical trial data that were published in the New England Journal of Medicine, showing an overall response rate (ORR) of nearly 68 per cent based on investigator assessment.2 IMBRUVICA® is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. markets IMBRUVICA® in Canada.

IMBRUVICA® was first approved in Canada in November 2014 for the treatment of patients with the blood cancer 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. For this clinical use, IMBRUVICA® was issued marketing authorization without conditions.3

Health Canada has issued a marketing authorization with conditions under the NOC/c policy for IMBRUVICA® in the treatment of patients with relapsed or refractory MCL to reflect the promising nature of the clinical data.4 Under this policy, Janssen Inc. will provide Health Canada with data from additional studies to confirm the clinical benefit of IMBRUVICA®.

"Mantle cell lymphoma patients who are refractory or relapsed traditionally have few therapies to consider, so ibrutinib offers an excellent option for this high unmet need," said Dr. Laurie Sehn, Chair, Lymphoma Tumour Group, BC Cancer Agency. "The availability of ibrutinib will give relapsed or refractory MCL patients an effective, new, oral, once-daily, targeted treatment option." *

Mantle cell lymphoma is a rare and aggressive form of blood cancer which arises from B cells, a type of white blood cell (lymphocyte) that originates in the bone marrow.5'6 In Canada, close to 500 new cases of MCL are diagnosed each year.7 MCL makes up about six per cent of all non-Hodgkin lymphomas, affects more men than women, and usually occurs in adults over 50 years of age.8. The disease behaves aggressively and grows quickly,9 and is typically associated with a poor prognosis.10

The safety and efficacy of IMBRUVICA® in patients with MCL were evaluated in an open-label, multi-center, single-arm phase 2 study of 111 patients who had received at least one prior therapy. The primary endpoint of the study was ORR based on responses assessed according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria.11

The most commonly occurring adverse reactions12 (≥ 20 per cent) in the clinical trial were diarrhea (53 per cent), fatigue (43 per cent), nausea (32 per cent), peripheral edema (30 per cent), dyspnea (28 per cent), constipation (28 per cent), upper respiratory tract infection (26 per cent), vomiting (23 per cent), decreased appetite (23 per cent), and thrombocytopenia (21 per cent).13

Approximately 10 per cent of patients receiving IMBRUVICA® in the clinical trial discontinued treatment due to adverse events. The most frequent adverse reaction leading to treatment discontinuation was subdural hematoma (1.8 per cent).14

About IMBRUVICA® (ibrutinib)
IMBRUVICA® contains the medicinal ingredient ibrutinib which is a targeted inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib blocks BTK activity, inhibiting cancer cell survival and spread.15 

IMBRUVICA® is indicated 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. Clinical effectiveness of IMBRUVICA® in the frontline setting is based on the benefit observed in CLL patients with 17p deletion who have received at least one prior therapy. Clinical trial data in the frontline setting are very limited.

IMBRUVICA®, indicated for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL), has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. The recommended dose of IMBRUVICA® for MCL is 560 mg (four 140-mg capsules) once daily.16

About Janssen Inc.
Janssen Inc. and Cilag GmbH International are members of the Janssen Pharmaceutical Companies, which are dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Please visit www.janssen.ca for more information.

* Dr. Sehn was not compensated for any media work. She has been a paid consultant to Janssen Inc.

References:

1 IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. Updated July 24, 2015

2 Wang ML, Rule S, Martin P, et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med 2013 Jun 19

3 IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. Updated July 24, 2015

4 Health Canada: Notice of Compliance with Conditions (NOC/c). Accessed on July 6 from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/index-eng.php

5 Leukemia and Lymphoma Society. Mantle Cell Lymphoma Facts Accessed on June 18 from: http://www.llscanada.org/content/nationalcontent/resourcecenter/freeeducationmaterials/lymphoma/pdf/mantlecelllymphoma.pdf

6 Canadian Cancer Society Statistics. Accessed on June 25 from http://www.cancer.ca/en/cancer-information/cancer-type/non-hodgkin-lymphoma/non-hodgkin-lymphoma/?region=on

7 Canadian Cancer Society Statistics. Accessed on June 25 from www.cancer.ca/en/cancer-information/cancer-101/canadian-cancer-statistics-publication/?region=on

8 Canadian Cancer Society. Mantle Cell Lymphoma. Accessed on June 18 from http://www.cancer.ca/en/cancer-information/cancer-type/non-hodgkin-lymphoma/non-hodgkin-lymphoma/types-of-nhl/mantle-cell-lymphoma/?region=on

9 Canadian Cancer Society. Mantle Cell Lymphoma. Accessed on June 18 from: http://www.cancer.ca/en/cancer-information/cancer-type/non-hodgkin-lymphoma/non-hodgkin-lymphoma/types-of-nhl/mantle-cell-lymphoma/?region=on

10 Leukemia and Lymphoma Society. Mantle Cell Lymphoma Facts. Accessed on June 18 from:
http://www.lls.org/sites/default/files/file_assets/mantlecelllymphoma.pdf

11 IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. Updated July 24, 2015

12 IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. Updated July 24, 2015

13 IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. Updated July 24, 2015

14 IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. Updated July 24, 2015

15 IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. Updated July 24, 2015

16 IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. Updated July 24, 2015

SOURCE Janssen Inc.

For further information: Media Contact: Shellie Suter, Office: (416) 382-5044; Investor Contact: Lesley Fishman, Office: (732) 524-3922


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