Ibrutinib FDA-approved for WM as first targeted therapy

In January 2015, ibrutinib became the first FDA-approved targeted agent for WM based on a pivotal phase II trial showing 90.5% overall response rate in previously treated patients. Ibrutinib's efficacy is tied to dual inhibition of BTK and HCK signaling downstream of MYD88 L265P, transforming WM management from chemoimmunotherapy to oral targeted therapy.