Singapore: The US FDA has granted 'Breakthrough Therapy Designations' for Janssen Research and Development's investigational oral agent ibrutinib, which is used as a monotherapy for B-cell malignancies in patients with relapsed or refractory mantle cell lymphoma (MCL) who have received prior therapy, and in patients with Waldenström's macroglobulinemia (WM). Janssen is now a part of the Johnson & Johnson group.

The Breakthrough Therapy Designation, which was enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), is intended to expedite the development and review time for a potential new medicine "to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development."

Dr Paul Stoffels, chief scientific officer and worldwide chairman, pharmaceuticals, Johnson & Johnson, said that, "We are pleased that the FDA has granted two Breakthrough Therapy Designations for ibrutinib as the designation represents a major leap forward in accelerating drug development timelines."

He also added, "We are committed to realizing the full potential of ibrutinib for patients with mantle cell lymphoma, Waldenström's macroglobulinemia, as well as other B-cell malignancies, and will work with Pharmacyclics and the FDA to ensure the clinical development program for ibrutinib continues to move forward as quickly as possible."

Janssen Biotech and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize ibrutinib. The filing for ibrutinib in MCL is expected to be made prior to the end of 2013 and discussions with the FDA about filing in WM continue. The implications of Breakthrough Therapy Designation cannot be determined at this time. Janssen and Pharmacyclics are working with the FDA to determine any potential implications of the Breakthrough Therapy Designations to the ongoing and planned development activities.