FDA Approves Imbruvica With Gazyva for First-Line CLL Treatment

The labeling for ibrutinib (Imbruvica, Pharmacyclics/Janssen) has been expanded to include use in combination with obinutuzumab (Gazyva, Genentech) in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

This is the first approval for a non–chemotherapy-related combination regimen for treatment-naive patients with CLL/SLL, and the 10th FDA approval for the Bruton’s tyrosine kinase inhibitor ibrutinib since its U.S. launch in November