NDA Submitted for Ibrutinib for Leukemia, Lymphoma

Janssen R&D announced that it has submitted a New Drug Application (NDA) for ibrutinib to the FDA for its use in the treatment of previously treated patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and for its use in the treatment of previously treated patients with mantle cell lymphoma (MCL). Ibrutinib is an investigational oral Bruton's tyrosine kinase (BTK) inhibitor.

The regulatory submission for ibrutinib is supported by data from two pivotal Phase 2 studies, one in relapsed/refractory CLL/SLL (PCYC-1102) and one in relapsed/refractory MCL (PCYC-1104).

In February 2013, ibrutinib was granted Breakthrough Therapy Designation from the FDA as monotherapy for the treatment of patients with relapsed/refractory MCL and for the treatment of patients with CLL/SLL with deletion of the short arm of chromosome 17 (del 17p).

For more information visit www.janssenrnd.com or www.pharmacyclics.com.