FDA Accepts, Grants Priority Review for Imbruvica's sNDA
Pharmacyclics announced that the FDA has accepted for filing the supplemental New Drug Application (sNDA) to extend the indication of Imbruvica (ibrutinib) to 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.
Included in the sNDA is data from the Phase 3 PCYC-1112-CA (RESONATE) study, a randomized, multi-center, open-label study which enrolled patients with CLL or SLL (n=391) who received at least one prior therapy. The study compared once-daily oral Imbruvica to intravenous ofatumumab in these patients. The trial was halted in January 2014 upon discovery of significant improvement in progression-free survival and overall survival with Imbruvica vs. ofatumumab during a pre-planned interim analysis.
Imbruvica, an antagonist of the Bruton's tyrosine kinase (BTK), inhibits cancer cell spread and proliferation by interrupting signals in B cells to mature and produce antibodies.
Imbruvica is already FDA approved for patients with CLL or mantle cell lymphoma (MCL) who received at least one prior therapy.
For more information visit Pharmacyclics.com.