Posted by Michael Wonder on 19 Jan 2017
U.S. FDA approves Imbruvica (ibrutinib) as first treatment specifically indicated for relapsed/refractory marginal zone lymphoma - a rare type of non-Hodgkin's lymphoma
19 January 2017 - Imbruvica will be a chemotherapy-free option for patients with marginal zone lymphoma who failed prior therapies.
AbbVie today announced the U.S. FDA approved Imbruvica (ibrutinib) for the treatment of patients with relapsed/refractory marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy.
This indication is approved under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Imbruvica is jointly developed and commercialised by Pharmacyclics, an AbbVie company, and Janssen Biotech, Inc.
