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.

The approval of Imbruvica in combination with CD20 antibody obinutuzumab was based on the Phase III iLLUMINATE study. The 212-patient open-label trial tested Imbrivica+obinutuzumab versus obinutuzumab+chlorambucil (a chemotherapy treatment). At a median follow-up of about 31 months, the Imbruvica regimen helped patients live longer without their disease progressing compared to the chemotherapy regimen (19 months), with 77% reduction in risk of progression or death, J&J said.

CLL is a common type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells, and accounts for about one-quarter of the new cases of leukemia, according to the American Cancer Society, which estimates about 20,720 new CLL cases will occur in 2019. SLL is a slow-growing lymphoma biologically similar to CLL in which too many immature white blood cells cause lymph nodes to become larger than normal.