FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Health Canada Approves Janssen’s Imbruvica for Chronic Lymphocytic Leukemia

Nov. 20, 2019

Health Canada approved Janssen’s Imbruvica (ibrutinib) in combination with obinutuzumab for treatment-naïve patients with active chronic lymphocytic leukemia (CLL).

The approval was based on data from a phase 3 clinical trial, in which Imbruvica plus the chemotherapy drug showed a significant improvement in progression-free survival.

The approval is the ninth indication for Imbruvica in Canada, and the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with CLL.

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