Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Pharmaceuticals, Inc.Apr 8 2014

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. This regulatory submission is based on data from the Phase 3 RESONATE™ study in relapsed or refractory chronic lymphocytic leukemia (CLL). IMBRUVICA is being jointly developed and commercialized by Janssen and Pharmacyclics.

In February 2014, IMBRUVICA received FDA approval to treat patients with CLL who have received at least one prior therapy. This indication is based on an overall response rate (ORR) from Phase 2 data and an improvement in survival or disease-related symptoms has not been established. The current approval was granted under the FDA's Accelerated Approval regulations and required the completion of an additional, larger Phase 3 trial to verify clinical benefit.

The Phase 3 PCYC-1112 (RESONATE) study is a randomized, multi-center, open-label study, which compares once-daily oral IMBRUVICA versus intravenous ofatumumab in 391 patients with CLL or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. The RESONATE trial was halted early in January 2014 based on the recommendation of an Independent Data Monitoring Committee (IDMC) at the formal pre-planned interim analysis, which found IMBRUVICA was associated with a significant improvement in progression-free survival (the primary endpoint of the study) versus ofatumumab, and in overall survival (a key secondary endpoint of the trial). Data from this study were accepted and will be presented at the upcoming 50^th annual meeting of the American Society of Clinical Oncology.

"This sNDA is the first Phase 3 submission for IMBRUVICA in the U.S. and represents a growing and more mature body of clinical evidence to support the use of IMBRUVICA in patients with chronic lymphocytic leukemia who have received prior therapy," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. "We and our collaboration partner Pharmacyclics are focused on ways to bring this medicine to patients as quickly as possible and this is one more important milestone in the development of this product."

CLL is a slow-growing blood cancer of white blood cells called lymphocytes, most commonly B cells. CLL is the most common adult leukemia in the Western world and predominantly a disease of the elderly with a median age of diagnosis of 72. This orphan disease often eventually progresses; patients are faced with fewer treatment options and are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.