The first oncology drug receiving three breakthrough designations –The IMBRUVICA story
View Presentation View Presentation
Maria Fardis, Pharmacyclics Inc  Clow Fong, Pharmacyclics Inc.  Urte Gayko, Pharmacyclics Inc  Jesse McGreivy, Pharmacyclics Inc  *Sudhakar Rao, Janssen pharmaceutical & development  Steven Sun, Janssen pharmaceutical & development 

Keywords: Breakthrough designation, accelerated approval, Imbruvica

Breakthrough designation was part of the 2012 FDA Safety and Innovation Act (FDASIC). This designation was intended to improve patient access to innovative treatments, including enhancements to accelerated approval and providing new authority for FDA to work more closely with sponsors on “efficient” development programs for breakthrough therapies. ImbruvicaTM (Ibrutinib) is the first oncology therapeutic developed jointly by Pharmacyclics and Janssen, received Breakthrough Designation for MCL indication in Feburary 2013. It was subsequently awarded two other Breakthrough Therapy Designations: for Waldenstrom’s Macroglobulinemia (WM) (February 2013) and for CLL del p17 subpopulation (March 2013). On November 13, 2013, ImbruvicaTM was approved for Mantle Cell Lymphoma (MCL) in the United States for patients who have received at least one prior therapy. It was subsequently approved in the U.S. on February 13, 2014 for Chronic Lymphocytic Leukemia (CLL) for patients who have received at least one prior therapy. In this presentation, we will share some highlights from this journey and discuss the benefits throughout the development program as a result of being awarded Breakthrough Therapy Designation.