FDA expands approval of Imbruvica for CLL-Janssen Biotech/Pharmacyclics

The FDA has approved the supplemental New Drug Application for Imbruvica (ibrutinib) capsules, from Janssen Biotech and Pharmacyclics, for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy. The FDA also approved Imbruvica for CLL patients with del 17p, a genetic mutation that occurs when part of chromosome 17 has been lost. CLL patients with del 17p are considered to have the poorest prognosis.

The update to the label is based on data from the Phase III RESONATE study, which demonstrated Imbruvica significantly improved progression-free survival (PFS) and overall survival (OS) versus ofatumumab in patients with previously treated CLL or small lymphocytic leukemia (SLL). Imbruvica was initially approved in February 2014 under Subpart H regulation, the FDA's accelerated approval process, based on data from a Phase Ib/II study for patients with CLL who have received at least one prior therapy.