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

Self-collection kits for HPV are among innovations adding momentum to eradication of cervical cancerA kit for at-home unsupervised self-collection clears FDA finish line

Long-awaited results from first phase III trial of a RAS inhibitor in pancreatic cancer shows that daraxonrasib doubles median OSPanCAN’s Berkenblit: “It’s here. This is a tipping point, and we’ve tipped. And this is just the beginning.”

Calabresi’s “Cancer at a Crossroads” report was the first step toward historic doubling of the NIH budgetFox Chase’s Winn contemplates Crossroads 2.0

Most Favored Nation drug pricing could put China on top

Bridging communication and genomics: A path toward equitable cancer care

FDA adds stereotactic breast biopsy needles to the shortage list

Never miss an issue!

Login

Self-collection kits for HPV are among innovations adding momentum to eradication of cervical cancer
A kit for at-home unsupervised self-collection clears FDA finish line

Long-awaited results from first phase III trial of a RAS inhibitor in pancreatic cancer shows that daraxonrasib doubles median OS
PanCAN’s Berkenblit: “It’s here. This is a tipping point, and we’ve tipped. And this is just the beginning.”

Calabresi’s “Cancer at a Crossroads” report was the first step toward historic doubling of the NIH budget
Fox Chase’s Winn contemplates Crossroads 2.0