FDA grants 'Breakthrough Therapy Designation' to ibrutinib for treatment of relapsed or refractory mantle cell lymphoma and Waldenstrom's macroglobulinemia

Source: BioSpace , PharmaTimes Area: News The FDA has granted 'Breakthrough Therapy Designation' to ibrutinib (as monotherapy) for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL) and for the treatment of patients with Waldenstrom's macroglobulinemia (WM).   Ibrutinib is an investigational oral agent designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK), a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel regulating apoptosis, adhesion, and cell migration and homing.   The Breakthrough Therapy Designation is intended to expedite the development and review of a potential new drug 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."   ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news