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

YOU MAY BE INTERESTED IN

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Michael Caputo appointed to President’s Cancer PanelThe cancer survivor and political operative says his appointment signals Trump’s interest in cancer, survivorship

Two years after FDA’s breast density notification rule, there is still no standard for follow-upSo far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy“Because it works in one neural system, you begin to wonder: Well, what about another?”

ASCO Genitourinary Cancers Symposium: Pioneering breakthroughs, optimizing patient outcomes

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Never miss an issue!

Login

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two
“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Michael Caputo appointed to President’s Cancer Panel
The cancer survivor and political operative says his appointment signals Trump’s interest in cancer, survivorship

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”