The first oncology drug receiving three breakthrough designations –The IMBRUVICA story
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.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC