Pharmacyclics, Inc, and Janssen Biotech, Inc, have announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA), based on data from the randomized, multicenter, open-label phase III RESONATE study, a head-to-head comparison of single-agent ibrutinib (Imbruvica) vs ofatumumab (Arzerra) in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma who had received at least one prior therapy.
At a planned interim analysis in January 2014, the results of the RESONATE study demonstrated a statistically significant improvement in progression-free survival, the primary endpoint of the study, in patients treated with ibrutinib. Further, patients in the ibrutinib arm also showed a statistically significant improvement in overall survival, a key secondary endpoint of the trial. The safety profile of ibrutinib was acceptable and showed a favorable risk benefit profile. Data from this study will be discussed in a presentation at the 2014 ASCO Annual Meeting in Chicago, May 30 to June 3, 2014.
The FDA granted an accelerated approval for ibrutinib as a single agent for the treatment of patients with mantle cell lymphoma or CLL, who have received at least one prior therapy. ■