FDA Gives Ibrutinib New 'Breakthrough Therapy Designation'


The U.S. Food and Drug Administration has announced that it has granted "Breakthrough Therapy Designation" for the investigational agent ibrutinib as a monotherapy for relapsed or refractory mantle cell lymphoma (MCL) and Waldenström’s macroglobulinemia.

Ibrutinib is a tyrosine kinase inhibitor that selectively inhibits the Bruton’s tyrosine kinase enzyme, which has been associated with the regulation of cell death, cell adhesion, and cell migration, and which helps the microenvironment of the tumor survive.

Ibrutinib, developed by both Janssen Biotech, Inc. and Pharmacyclics, is currently being investigated for the treatment of chronic lymphocytic leukemia, diffuse large B-cell lymphoma, follicular lymphoma, and multiple myeloma, as well as both of the breakthrough designations, mantle cell lymphoma and Waldenström’s macroglobulinemia.

New FDA designation speeds up development and review process

"Breakthrough Therapy Designation" is a new FDA designation created in 2012 along with the FDA Safety and Innovation Act (FDASIA). The point is to speed up the time needed to develop and review drugs that "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."

Said Paul Stoffels, MD, Chief Scientific Officer and Worldwide Chairman of Pharmaceuticals at Johnson & Johnson:

“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, 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."

Source: OncLive

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