Pharmacyclics/Janssen win FDA OK for Imbruvica in Waldenstrom's
This article was originally published in Scrip
Executive Summary
The FDA on 29 January gave the go-ahead for Janssen Biotech and its partner Pharmacyclics to market Imbruvica (ibrutinib) as a treatment for Waldenstrom's macroglobulinemia (WM), a rare, indolent type of B-cell lymphoma – the first therapy ever approved in the US specifically the disease.