by the Food and Drug Administration.
Ibrutinib, a Bruton’s tyrosine kinase inhibitor, is already approved as a single agent for WM. The addition of rituximab to the indication is based on positive results from the phase 3 INNOVATE study. In particular, the trial showed a superior progression-free survival rate at 30 months for the ibrutinib-rituximab combination at 82%, compared with placebo plus rituximab at 28% ().
The study’s lead investigator, Meletios A. Dimopoulos, MD, called the combination a “new standard of care” for WM at the recent annual meeting of the American Society of Clinical Oncology.
, marketed as Imbruvica, is jointly developed and commercialized by Pharmacyclics and Janssen Biotech.