Health Canada Approves Imbruvica In Mantle Cell Lymphoma

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.

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Health Canada Approves Imbruvica In Mantle Cell Lymphoma

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Health Canada Approves Imbruvica In Mantle Cell Lymphoma

YOU MAY BE INTERESTED IN

Early-onset colorectal cancer is behaving like a new, biologically distinct disease, researchers noteOne woman’s pregnancy shows how this distinction matters

Maura Gillison, who identified the role of HPV in head and neck cancer, changing the standard of care, dies at 61

Is it time to re-assess the practice and practicality of screening colonoscopy?Modeling data in ACS guideline support greater use of noninvasive tests to ease system strain, save lives

More than 50 million Americans remain unscreened for colon cancerNew guidelines offer another option

AACR urges OMB to retract proposed rule on federally funded research

CDC updates ACIP charter

Never miss an issue!

Login

Early-onset colorectal cancer is behaving like a new, biologically distinct disease, researchers note
One woman’s pregnancy shows how this distinction matters

Is it time to re-assess the practice and practicality of screening colonoscopy?
Modeling data in ACS guideline support greater use of noninvasive tests to ease system strain, save lives

More than 50 million Americans remain unscreened for colon cancer
New guidelines offer another option