FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Jun 9 2014

Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval. The sNDA was submitted to the FDA based on data from the randomized, multi-center, open label Phase III RESONATE™ trial, PCYC-1112-CA, a head-to-head comparison of IMBRUVICA™ versus ofatumumab in 391 patients with CLL or SLL who had received at least one prior therapy. The target date as defined by the Prescription Drug User Fee Act by which the FDA is planning to finalize the review of this application (PDUFA date) is October 7, 2014.

"We are pleased to have received the acceptance of our sNDA filing by the FDA. We believe the data set that we have submitted is compelling," said Dr. Urte Gayko, Senior Vice President of Global Regulatory Affairs, Pharmacyclics. "We look forward to continuing to work with the FDA as they complete their review of this application."