Pharmacyclics MCL/WM drug ibrutinib wins FDA 'breakthrough' designation
This article was originally published in Scrip
Executive Summary
Shares of Pharmacyclics jumped as high as 9.5% on 13 February after the company revealed it has won the breakthrough therapy designation from the US FDA for the Sunnyvale, California-based biotech's ibrutinib, which is under investigation as a monotherapy to treat patients with relapsed or refractory mantle cell lymphoma (MCL) or Waldenstrom's macroglobulinemia (WM) – both B-cell malignancies.