- The approval is based on P-III E1912 study assessing Imbruvica + rituximab (IR) followed by ibrutinib until disease progression or unacceptable toxicity, or six cycles of FCR in 529 previously untreated CLL patients aged ≤70 yrs.
- Results: @median follow-up of 37 mos. IR treated patients lived longer without disease progression with a PFS (88 %), compared to 75 % for FCR treated patients. The study also showed an OS advantage for the IR regimen
- Ibrutinib (oral, qd) is a first-in-class BTK inhibitor that blocks the BTK protein and helps abnormal B cells movement out of their nourishing environments in the lymph nodes, bone marrow, and other organs. Ibrutinib is approved for CLL, MCL, and WM in Europe and in 99+ countries for at least one indication
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