Pharmacyclics Files SNDA For IMBRUVICA With Phase III CLL Study Data

(RTTNews) - Pharmacyclics, Inc. (PCYC) Tuesday said it has submitted a supplemental New Drug Application, or sNDA, to the U.S. Food and Drug Administration, or FDA, seeking full approval for the use of IMBRUVICA, based on data from its Phase III RESONATE study

IMBRUVICA is the first once-daily, single-agent, oral kinase inhibitor for patients with mantle cell lymphoma or MCL and chronic lymphocytic leukemia or CLL, who have received one prior therapy, and is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

The results of the RESONATE study showed a statistically significant improvement in progression-free survival, the primary endpoint of the study, in patients treated with IMBRUVICA. Further, patients also showed a statistically significant improvement in overall survival, a key secondary endpoint of the trial. The safety profile of IMBRUVICA was acceptable and showed a favorable risk benefit profile.

Previously, the FDA had granted an accelerated approval for IMBRUVICA as a single agent for the treatment of patients with MCL or CLL, who have received at least one prior therapy.

The accelerated approval for these indications was based on the overall response rate of patients in the Phase II clinical studies of PCYC-1102 and PCYC-1104. However, an improvement in survival or disease-related symptoms was not established in these studies.