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) 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. 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.

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.

For more details, go to: http://www.newswire.ca/en/story/1577711/imbruvica-ibrutinib-approved-with-conditions-for-relapsed-or-refractory-mantle-cell-lymphoma-patients