Cancer, FDA

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.


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,900+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

Visit Endpoints Careers ->