Janssen, a subsidiary of J&,J, together with Pharmacyclics, have announced that the FDA has granted two Breakthrough Therapy Designations to the investigational oral agent ibrutinib that the two companies were co-developing.
Ibrutinib is being developed as a monotherapy for two B-cell malignancies in patients with relapsed or refractory mantle cell lymphoma (MCL) who have received prior therapy, and it also being developed for use in patients with Waldenstrom’s macroglobulinemia (WM).
Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy Designation is intended to advance the development and review time for a potential new medicine to treat a serious or life-threatening disease or condition.
"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. We are committed to realizing the full potential of ibrutinib for patients with mantle cell lymphoma, Waldenstrom'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."
Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson &, Johnson.
"This is a historic moment in oncology. We are truly honored to have received this Breakthrough Designation and are pleased for patients and clinicians with the FDA's decision to expedite the development of ibrutinib. This compound entered the clinic in 2009 and has demonstrated tremendous clinical progress over the past four years. I would like to thank our collaboration partner, Janssen, for their support. Together we are committed to bringing this new therapeutic to patients and health care providers."
Bob Duggan, CEO and Chairman of the Board, Pharmacyclics.
Janssen Biotech and Pharmacyclics entered into a collaboration and license agreement in December 2011, with the aim to co-develop and co-commercialise ibrutinib. The filing for ibrutinib in MCL is expected to be made before the end of 2013.