J&J submits leukemia drug - ibrutinib - to FDA for approval

J&J today announced that it had submitted ibrutinib, an investigational oral BTK inhibitor, to the FDA for approval of the treatment of two B-Cell Malignancies.

The treatment was submitted specifically 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)'.

If approved the drug could address a high unmet need in relapsed / refractory chronic lymphocytic leukemia and relapsed / refractory mantle cell lymphoma. In addition, it would be the first in a class of oral BTK inhibitors to be approved and is one of the first medicines to file for FDA approval via the new Breakthrough Therapy Designation pathway.

"The FDA submission is another important milestone for ibrutinib since we formed our strategic partnership with Pharmacyclics just 18 months ago. Both companies recognize that there is great unmet need among these patient populations, and together in close collaboration with the FDA, as part of its Breakthrough Therapy Designation pathway, we have been able to accelerate the ibrutinib development program for the benefit of patients."

Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen.

The submission to the FDA is supported by data from two pivotal Phase 2 studies.