The loss of two indications for AbbVie Inc. and Johnson & Johnson’s Imbruvica (ibrutinib), for mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL), are relatively small markets for the BTK inhibitor, but their withdrawal from Imbruvica’s label potentially clears the way for newer BTK inhibitors, provided their confirmatory trials are more successful.
The Janssen Pharmaceutical Companies of J&J and AbbVie’s Pharmacyclics subsidiary said 6 April said they would voluntarily withdraw the US indications for Imbruvica in MCL patients who have at least one prior therapy, which gained accelerated approval in 2013, along with MZL in patients who require systemic therapy and have received at least one prior therapy with CD20-targeted monoclonal antibody treatment, which followed in 2017
