Another Breakthrough Designation Added to Ibrutinib

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The US Food and Drug Administration (FDA) has granted a third so-called Breakthrough Therapy Designation for the investigational oral agent ibrutinib, developed jointly by Pharmacyclics and Janssen, as monotherapy for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients with deletion of the short arm of chromosome 17 (deletion 17p).

Chemo-immunotherapy tends to be ineffective in patients who have this specific deletion, and their treatment options are very limited. To that end, having this deletion is considered among the worst prognostic factors in patients with CLL/SLL.

This past February, the FDA granted Breakthrough Therapy Designations for ibrutinib as a monotherapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL) and as a monotherapy for the treatment of patients with Waldenstrom's macroglobulinemia (WM).

Breakthrough Therapy Designation is designed to hasten the development and review of drugs for serious or life-threatening diseases where "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," according to the FDA.

Breakthrough Therapy Designation is an aspect of the 2012 Food and Drug Administration Safety and Innovation Act.

Source: FDA

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