Priority Review for Imbruvica for CLL, SLL

Pharmacyclics Inc. (NASDAQ:PCYC) said FDA accepted and granted Priority Review to an sNDA seeking full approval of Imbruvica ibrutinib to treat chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) in patients who have received at least one prior therapy. The PDUFA date is Oct. 7. Imbruvica already has accelerated approval from FDA for the CLL indication and for mantle cell lymphoma (MCL) in patients who have received at least one prior therapy.

The sNDA is based on data from the Phase III RESONATE (PCYC-1112-CA) trial, which was stopped early after an interim analysis in January showed that Imbruvica met the primary endpoint of improving progression-free survival (PFS) vs. IV Arzerra ofatumumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in in patients with relapsed or refractory CLL or SLL (see BioCentury, Jan. 13). ...