www.fdanews.com/articles/193507-health-canada-approves-janssens-imbruvica-for-chronic-lymphocytic-leukemia
Health Canada Approves Janssen’s Imbruvica for Chronic Lymphocytic Leukemia
November 19, 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.