Imbruvica regimen wins FDA approval as first non-chemotherapy treatment for untreated patients with common form of leukemia

In the 10th approval since its 2013 launch, J&J?s cancer drug Imbruvica has secured the FDA nod in combination with Roche?s?obinutuzumab in adults with the most common form of leukemia?? marking the first non-chemotherapy regimen for treatment-na?ve?patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

The approval expands the use of Imbruvica?? which is also sold by AbbVie?? in frontline CLL/SLL beyond its use as a monotherapy. The drug itself generated sales of about $2.6 billion last year. The blockbuster treatment has seen steady growth in market share, leading the United States in first and second line CLL as well as second-line mantle cell lymphoma (MCL), an