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-naïve 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), and is the total patient share leader in Waldenstrom macroglobulinemia (WM) — a type of non-Hodgkin lymphoma — according to Credit Suisse.
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