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Health Canada Authorizes IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination with Venetoclax for Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) - Thu Mar 23, 4:07PM CDT

All-oral, once-daily, fixed-duration combination regimen authorized for first-line treatment of CLL

TORONTO, March 23, 2023 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has issued a Notice of Compliance (NOC) authorizing the expanded use of IMBRUVICA® (ibrutinib) in a first all-oral, fixed-duration (FD) treatment combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukemia (CLL), including those with 17p deletion (del 17p).1 This authorization is based on the pivotal Phase 3 GLOW study that demonstrated statistically significant improvement in progression-free survival (PFS) in patients treated with I+V versus chlorambucil and obinutuzumab (Clb+O), and the FD cohort of the Phase 2 CAPTIVATE study, which showed deep and durable responses in patients treated with I+V.1


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