Health Canada issued a Notice of Compliance with Conditions for Imbruvica (ibrutinib) an oral, once-daily single-agent therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma.
The approval with conditions is based on phase II clinical trial data that were published in the New England Journal of Medicine, showing an overall response rate of nearly 68 percent 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, 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.
