EC Expands Authorization of Janssen’s Imbruvica to Include CLL

The European Commission (EC) has expanded its marketing authorization of Janssen’s Imbruvica (ibrutinib) to include adult patients with previously untreated chronic lymphocytic leukemia (CLL).

Specifically, the expanded authorization allows for the use of Imbruvica as a combination regimen with venetoclax.

The expanded authorization is based on results from two studies that showed the combination treatment led to superior progression-free survival.

The drug is also authorized in the EU for use in patients with mantle cell lymphoma whose disease does not respond to or has returned after previous treatment and in patients with Waldenström’s macroglobulinemia, a rare blood cell cancer characterized by an abnormal number of white blood cells in the bone marrow.