FDA approves Imbruvica in marginal zone lymphoma

FDA granted accelerated approval to Imbruvica ibrutinib from AbbVie Inc. (NYSE:ABBV) and Johnson & Johnson (NYSE:JNJ) to treat relapsed or refractory marginal zone lymphoma (MZL), a type of non-Hodgkin's lymphoma (NHL). Specifically, the drug is approved to treat patients who require systemic therapy and have received at least one prior anti-CD20-based therapy. The drug is the first to be approved in the U.S. for the indication.

AbbVie said FDA based the approval on data from the Phase II PCYC-1121 trial, in which Imbruvica led to an overall response rate (ORR) of 46% in relapsed or refractory MZL patients...