Supplemental New Drug Application Submitted for Ibrutinib in CLL

Get Permission

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.  ■




By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.