Janssen R&D and Pharmacyclics Submit sNDA for Imbruvica
Janssen R&D and Pharmacyclics announced the submission of a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib), based on positive data from the Phase 3 RESONATE study in relapsed or refractory chronic lymphocytic leukemia (CLL). 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.
The Phase 3 PCYC-1112 (RESONATE) study is a randomized, multi-center, open-label study which enrolled patients with CLL or small lymphocytic lymphoma (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 is already FDA approved for patients with CLL or mantle cell lymphoma (MCL) who received at least one prior therapy, and was among the first therapies in the US to receive FDA Breakthrough Therapy Designation.